472 Jobs in Uhwiesen

Senior Project Engineer, Aseptic Manufacturing

Schaffhausen, Schaffhausen J&J Family of Companies

Gestern

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Arbeitsbeschreibung

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at Function:**
Supply Chain Engineering
**Job Sub** **Function:**
Project Engineering
**Job Category:**
Scientific/Technology
**All Job Posting Locations:**
Schaffhausen, Switzerland
**Job Description:**
At Johnson & Johnson, we believe good health is the foundation of vibrant lives, thriving communities and forward progress. As the world's largest and most broadly-based healthcare company, we are committed to using our reach and size for good. We strive to improve access and affordability, create healthier communities, and put a healthy mind, body and environment within reach of everyone, everywhere. Every day, our more than 130,000 employees across the world are blending heart, science and ingenuity to profoundly change the trajectory of health for humanity! Within the Pharmaceuticals division we are committed to making disease a thing of the past!
Cilag AG in Schaffhausen belongs to the group of Johnson & Johnson pharmaceutical companies operating under the "Janssen Pharmaceutical Companies of Johnson & Johnson" trademark and manufactures high quality pharmaceutical products, active pharmaceutical ingredients (APIs) and medical devices. Today Cilag AG is one of the largest pharmaceutical manufacturers in Switzerland supplying all the major global markets. The Schaffhausen facility is a strategic launch and growth site for parenteral products, and we have an impressive pipeline of new and innovative products.
We are looking for a Senior Project Engineer (m/f/d) with in our engineering team to lead technical projects for state of the art aseptic fill finish manufacturing equipment. As Project Engineer you will contribute to the design, installation and qualification of production equipment and utilities. You will drive various strategic investments that are required to keep our manufacturing assets suitable for manufacturing innovative medecines, safe, qualitative, reliable and sustainable.
**Key Responsibilities:**
+ Accountable for Engineering project management and project execution to high standards, ensure projects completed on time and on budget
+ Responsible and accountable for the safe execution of job activities in compliance with EHS guidelines, environmental, regulatory (cGMP), corporate site and team practices and procedures
+ Close collaboration with stakeholders on site (Business Units, QA, EHS&S, sustainability, etc) as well as with the global organization (MAM LM Platform, Engineering & Property Services)
+ Initiation of cases supporting the project funding approval processes
+ Provide feedback to sustainability strategy
+ The successful applicant will strive to perform to high standards at all times in line with our Credo and Standards of Leadership
**Qualifications**
**Education:**
+ University degree in Engineering, preferably Mechanical, Electrical, Industrial, Biotechnology, Pharmaceutical or Chemical field
**Experience and Skills:**
**Required:**
+ A minimum of 6 years of related business experience and a consistent track record in Project Engineering in the pharmaceutical or chemical industry
+ Experience with aseptic manufacturing and thorough process understanding.
+ Excellent organization and communication skills with the ability to influence others and move toward a common vision or goal
+ Familiarity with project management approaches, engineering processes and design thinking methodology. Certification in FPX and or Lean processes are a plus.
+ Dedicated, well-organized and able to set own targets
+ Decisiveness, brainpower and determination to deal with various issues and projects simultaneously
+ Collaboration with others and work well in project teams
**Other:**
+ Language skills: Fluency (oral and written) in German and English with exceptional communication skills
+ This role may require occasionally regional travel, as needed (less than 10%)
Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit
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Staff Engineer MSAT Bio DP (1 year limited contract)

Schaffhausen, Schaffhausen J&J Family of Companies

Gestern

Job angesehen

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Arbeitsbeschreibung

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at Function:**
Supply Chain Engineering
**Job Sub** **Function:**
Process Engineering
**Job Category:**
Scientific/Technology
**All Job Posting Locations:**
Schaffhausen, Switzerland
**Job Description:**
Cilag AG, part of Johnson & Johnson, is recruiting for a **Staff / Senior Engineer, LM DP STO** within Manufacturing Science and Technology (MSAT) team, located in **Schaffhausen, Switzerland.**
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at more than 130 years, diversity, equity & inclusion (DEI) has been a part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Rooted in Our Credo, the values of DEI fuel our pursuit to create a healthier, more equitable world. Our diverse workforce and culture of belonging accelerate innovation to solve the world's most pressing healthcare challenges.
Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.
Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.
Learn more at and join us to create a future where disease is a thing of the past. At our Schaffhausen Site we launch new products with focus on Parenteral Products (e.g., Prefilled Syringes and vials).
We belong to the Manufacturing, Science & Technology (MSAT) organization for the MTO (Manufacturing and Technical Operations) Large and Small Molecule Manufacturing Platform. We support Small Molecule API and Drug Product operations and the Parenteral small and large molecule Filling, visual inspection, device assembly and pack operations at JSC Schaffhausen, Janssen Supply Chain and currently we are looking for a MSAT Validation Staff Engineer to be based in Schaffhausen, Switzerland to join our team.
**POSITION SUMMARY:**
You will be the Site MSAT representative on cross functional teams owning the responsibility for the reliability of product processes of commercial product and new product introductions for non-biologic and biologic parenteral liquids, suspensions, and lyophilized products at the Schaffhausen Fill Finish site. You will provide the following:
+ Technical support and leadership to top line growth
+ Enhance reliability, compliance & efficiency of product value chains end to end
+ Integrate Manufacturing Operations and Pharmaceutical Development in partnership with Product and Customer Management
**RESPONSIBILITIES:**
+ Site Technical Owner for New Product Introductions, Tech Transfer Projects and specific commercial product
+ Own and coordinate validation activities with internal partners
+ Lead cross functional project teams
+ Implement Process Capability/Quality/Cost Improvement Changes
+ Provide Technical Assessments to Change Controls/CAPAs and Deviations
+ Active participation in inspections as Subject Matter Expert
+ Maintain excellent partnership with all business partners
+ Execute statistical analyses on production data
**Qualifications:**
+ You have a Degree in Chemistry or Pharmacy or equivalent
+ You have 4+ years of experience in the pharmaceutical sector overall with past proven field experience in the following areas:
+ Parenteral drug product manufacturing
+ Quality Assurance and Regulatory Compliance cGMP
+ Leading GMP Investigations
+ Experience in the following fields are of advantage, but not a must:
+ DP manufacturing process validation
+ Leading cross-functional teams and project
+ Leading GMP investigations
+ You have strong decision making and problem-solving competencies
+ You are a flexible, motivated, and innovative team player
+ You are open to new ideas and driving innovation
+ You are proficient in English and you have basic German knowledge
**We are offering**
a multifaceted challenge in a dynamic, international environment with attractive terms and career opportunities as well as a good infrastructure at the Janssen site Schaffhausen.
+ Many opportunities to work on exciting projects and assignments.
+ Childcare benefit
+ A broad spectrum of training opportunities to grow further for personal as well as professional development
+ The Johnson & Johnson Pension Fund Switzerland offers attractive performance
+ A range of benefits for insurance, products, sport, culture and much more
+ 1 year limited contract to start with
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Manager, Customer Excellence Capability & Optimization

Schaffhausen, Schaffhausen J&J Family of Companies

Vor 2 Tagen gepostet

Job angesehen

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Arbeitsbeschreibung

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at Function:**
Supply Chain Deliver
**Job Sub** **Function:**
Deliver Excellence
**Job Category:**
Professional
**All Job Posting Locations:**
Schaffhausen, Switzerland
**Job Description:**
Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.
Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.
Learn more at ( ative-medicine.
We are searching for the best talent, **Manager, Customer Excellence Capability Optimization** **.**
**_Please note that this role is available across multiple countries and may be posted under different requisition numbers to comply with local requirements. While you are welcome to apply to any or all of the postings, we recommend focusing on the specific country(s) that align with your preferred location(s)_**
**_United States & Puerto Rico - Requisition Number:_** **R- **
**_Belgium - Requisition Number: R- _**
**_Switzerland- Requisitions Number: R- _**
**_High Wycombe, UK Requisition Number: _**
#LI-Hybrid
This position is responsible for the Customer Excellence capability which drives an improved and competitive customer service realized by effective global process design and standardization worldwide, through establishing and implementing standardized processes, procedures, performance metrics the ongoing governance and change control for IM customer service globally.
They will continually evolve standardization to further realize opportunities and improve order accuracy and customer satisfaction, whilst ensuring processes are compliant with all relevant quality and compliance standards.
All in alignment and collaboration with our Transcend roll out and ongoing governance of the template
**Process Ownership & Standardization**
+ Be responsible for the portfolio of global standards. Establish and drive a governance and process for prioritization and lifecycle management, including creation, review and retirement.
+ Develop, define, and own global customer service standards, ensuring they align with the overall strategy and vision.
+ Drive the design, documentation, and adoption of standardized processes worldwide.
**Continuous Improvement:**
+ Identify areas for improvement by analyzing performance data, customer feedback, and operational challenges.
+ Lead initiatives to optimize customer service workflows and resolve process inefficiencies while maintaining service quality and satisfaction.
+ Collaborate with regional teams to adapt standards to local needs, balancing consistency with local flexibility.
**Collaboration:**
+ Act as the key point of contact for process inquiries, providing direction and support to operational teams.
**Metrics & Reporting:**
+ Use data-driven insights to make informed recommendations and decisions, ensuring service levels meet or exceed customer expectations.
**Compliance & Risk Management:**
+ Ensure alignment with legal, regulatory, and company requirements across regions.
+ Ensure effective risk mitigation strategies are in place.
This position will enable new capabilities with ongoing focus on customer value and support marketplace growth.
+ Establish and implement standardized processes, procedures, governance and performance metrics for customer service, customer connectivity, order management operations across all regions globally.
+ Analyze end to end order management processes to optimize efficiency, minimize costs, and improve touchless order. Identify and define new process requirements to enhance and advance regional capabilities
+ Collaborate with regional stakeholders to enable scalable solutions on Process Optimization; work closely with regional Deliver teams, Finance and Quality partners to ensure alignment of value optimization initiatives with broader business priorities, transformation programs and customer expectations.
+ Manage cross functional-workstream business processes integration including Community of Practice. Develop and maintain the Capability Roadmap to ensure alignment with global process standards across all regions.
+ Lead the execution and analysis of maturity assessment outputs to identify areas for improvement.
+ Provides expert guidance on priority initiatives.
**Required Minimum Education** :
Bachelor's degree is required; advanced degree or MBA is highly desirable .
**Required Experience:**
+ Requires a minimum of 5 years of dynamic experience in roles, relating to process excellence and standardization for Customer Service.
+ Requires a minimum of 3 years of business process design, engineering, or optimization experience.
+ Requires 3 years of Global experience.
**Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.**
**Johnson and Johnson is committed to providing an interview process that is inclusive of our applicants' needs. If you are an individual with a disability and would like to request an accommodation, please email the Employee Health Support Center ( ) or contact AskGS to be directed to your accommodation resource.**
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Construction Manager Project Engineering (Fixed Term)

Schaffhausen, Schaffhausen J&J Family of Companies

Vor 2 Tagen gepostet

Job angesehen

Tippen Sie erneut, um zu schließen

Arbeitsbeschreibung

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at Function:**
Supply Chain Engineering
**Job Sub** **Function:**
Project Engineering
**Job Category:**
Scientific/Technology
**All Job Posting Locations:**
Schaffhausen, Switzerland
**Job Description:**
At Johnson & Johnson, we believe good health is the foundation of vibrant lives, thriving communities and forward progress. As the world's largest and most broadly-based healthcare company, we are committed to using our reach and size for good. We strive to improve access and affordability, create healthier communities, and put a healthy mind, body and environment within reach of everyone, everywhere. Every day, our more than 130,000 employees across the world are blending heart, science and ingenuity to profoundly change the trajectory of health for humanity! Within the Pharmaceuticals division we are committed to making disease a thing of the past!
Cilag AG in Schaffhausen belongs to the group of Johnson & Johnson pharmaceutical companies operating under the "Janssen Pharmaceutical Companies of Johnson & Johnson" trademark and manufactures high quality pharmaceutical products, active pharmaceutical ingredients (APIs) and medical devices. Today Cilag AG is one of the largest pharmaceutical manufacturers in Switzerland supplying all the major global markets. The Schaffhausen facility is a strategic launch and growth site for parenteral products, and we have an impressive pipeline of new and innovative products.
We are looking for a Construction Manager - Project Engineering (m/f/d) with in our engineering team to lead the implementation of infrastructure projects. As Construction Manager you will contribute to the design, installation and qualification of infrastructure and cleanrooms. You will drive various strategic investments that are required to keep our manufacturing assets suitable for manufacturing innovative medicines, safe, qualitative, reliable and sustainable.
**Key Responsibilities:**
+ Accountable for Engineering project management and project execution to high standards, ensure projects completed on time and on budget
+ Responsible and accountable for the safe execution of job activities in compliance with EHS guidelines, environmental, regulatory (cGMP), corporate site and team practices and procedures
+ Close collaboration with stakeholders on site (Business Units, QA, EHS&S, sustainability, etc) as well as with the global organization (MAM LM Platform, Engineering & Property Services)
+ Initiation of cases supporting the project funding approval processes
+ Provide feedback to sustainability strategy
+ The successful applicant will strive to perform to high standards at all times in line with our Credo and Standards of Leadership
**Qualifications**
**Education:**
+ University degree in Engineering, preferably Mechanical, Electrical, Industrial, Biotechnology, Pharmaceutical or Chemical field
**Experience and Skills:**
**Required:**
+ A minimum of 6 years of related business experience and a consistent track record in Project Engineering in the pharmaceutical or chemical industry
+ Excellent organization and communication skills with the ability to influence others and move toward a common vision or goal
+ Familiarity with project management approaches, engineering processes and design thinking methodology. Certification in FPX and or Lean processes are a plus.
+ Dedicated, well-organized and able to set own targets
+ Decisiveness, brainpower and determination to deal with various issues and projects simultaneously
+ Collaboration with others and work well in project teams
**Other:**
+ Language skills: Fluency (oral and written) in German and English with exceptional communication skills
+ This role may require occasionally regional travel, as needed (less than 10%)
Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit
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Sr Spec. QA Aseptic Expert & Oversight

Schaffhausen, Schaffhausen J&J Family of Companies

Vor 2 Tagen gepostet

Job angesehen

Tippen Sie erneut, um zu schließen

Arbeitsbeschreibung

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at Function:**
Quality
**Job Sub** **Function:**
Quality Assurance
**Job Category:**
Professional
**All Job Posting Locations:**
Schaffhausen, Switzerland
**Job Description:**
**Senior Specialist QA Aseptic Expert & Oversight, 80-100%, on-site**
**Zu den Haupttätigkeiten gehören unter anderem:**
+ Quality Oversight des aseptischen Produktionsbereichs vor Ort mit Fokus auf: aseptische Prozesse, Umgebungs- und Utilitiesmonitoring, Verhalten im Reinraum, Einkleiden und Desinfektion sowie Unterstützung in anderen Bereichen
+ Zeitgerechte Auswertung von Beobachtungen im Rahmen der Quality Oversight
+ Verantwortlichkeit für Qualifizierung von Mitarbeitern im aseptischen Bereich
+ Identifizierung von Risiken sowie Verbesserungspotentialen im aseptischen Bereich hinsichtlich Kontaminationskontrolle und aktive Umsetzung entsprechender Initiativen in enger Zusammenarbeit mit der Produktion, Qualitätsabteilung und dem Management
+ Kontrolle und Sicherung der Prozesse in der Pharmaproduktion unter Einhaltung aller GMP-relevanten Weisungen und Vorschriften
+ Koordination und Mithilfe bei der Analyse und Dokumentation von Abweichungen
+ Koordination und Mithilfe bei der Festlegung und Umsetzung korrigierender Massnahmen
+ Erstellung, Bearbeitung und Approval von Dokumenten (z.B. SOPs, WIs, MBRs) im TruVault-System
+ Leitung/ Vorantreibung von zugewiesenen Projekten
**Wen wir suchen:**
+ Berufsausbildung oder mehrjährige Erfahrung in der Pharma- oder Lebensmittelindustrie
+ Kenntnisse der aseptischer Herstellung sowie Erfahrung in eine Qualitätsrolle sind Voraussetzung
+ Schichtarbeit im 3-Schichtbetrieb
+ Bereitschaft zu gelegentlichen Wochenendeinsätze
+ Pro-Aktive und exakte Arbeitsweise
+ Sehr gute Kommunikationsfähigkeiten
+ Team Player
+ Gute IT-Anwenderkenntnisse
+ Sehr gute Deutschkenntnisse
+ Gute Englischkenntnisse in Wort und Schrift
Wenn Sie sich für diese spannende Aufgabe in einem international führenden Gesundheitsunternehmen interessieren, freuen wir uns auf Ihre vollständige Bewerbung!
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Sr Spec QA Aseptic Expert & Oversight

Schaffhausen, Schaffhausen J&J Family of Companies

Vor 2 Tagen gepostet

Job angesehen

Tippen Sie erneut, um zu schließen

Arbeitsbeschreibung

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at Function:**
Quality
**Job Sub** **Function:**
Quality Assurance
**Job Category:**
Professional
**All Job Posting Locations:**
Schaffhausen, Switzerland
**Job Description:**
**Senior Specialist QA Aseptic Expert & Oversight, 80-100%, on-site, befristet auf 2 Jahre**
**Zu den Haupttätigkeiten gehören unter anderem:**
+ Quality Oversight des aseptischen Produktionsbereichs vor Ort mit Fokus auf: aseptische Prozesse, Umgebungs- und Utilitiesmonitoring, Verhalten im Reinraum, Einkleiden und Desinfektion sowie Unterstützung in anderen Bereichen
+ Zeitgerechte Auswertung von Beobachtungen im Rahmen der Quality Oversight
+ Verantwortlichkeit für Qualifizierung von Mitarbeitern im aseptischen Bereich
+ Identifizierung von Risiken sowie Verbesserungspotentialen im aseptischen Bereich hinsichtlich Kontaminationskontrolle und aktive Umsetzung entsprechender Initiativen in enger Zusammenarbeit mit der Produktion, Qualitätsabteilung und dem Management
+ Kontrolle und Sicherung der Prozesse in der Pharmaproduktion unter Einhaltung aller GMP-relevanten Weisungen und Vorschriften
+ Koordination und Mithilfe bei der Analyse und Dokumentation von Abweichungen
+ Koordination und Mithilfe bei der Festlegung und Umsetzung korrigierender Massnahmen
+ Erstellung, Bearbeitung und Approval von Dokumenten (z.B. SOPs, WIs, MBRs) im TruVault-System
+ Leitung/ Vorantreiben von zugewiesenen Projekten
**Wen wir suchen:**
+ Berufsausbildung oder mehrjährige Erfahrung in der Pharma- oder Lebensmittelindustrie
+ Kenntnisse der aseptischen Herstellung sowie Erfahrung in eine Qualitätsrolle sind Voraussetzung
+ Schichtarbeit im 3-Schichtbetrieb
+ Bereitschaft zu gelegentlichen Wochenendeinsätze
+ Pro-Aktive und exakte Arbeitsweise
+ Sehr gute Kommunikationsfähigkeiten
+ Team Player
+ Gute IT-Anwenderkenntnisse
+ Sehr gute Deutschkenntnisse
+ Gute Englischkenntnisse in Wort und Schrift
Der Vertrag ist auf 2 Jahre befristet, was Flexibilität und die Möglichkeit zur Weiterentwicklung bietet.
Wenn Sie sich für diese spannende Aufgabe in einem international führenden Gesundheitsunternehmen interessieren, freuen wir uns auf Ihre vollständige Bewerbung!
Leider ist dieser Job in Ihrer Region nicht verfügbar

Specialist QA Aseptic Expert & Oversight

Schaffhausen, Schaffhausen J&J Family of Companies

Vor 2 Tagen gepostet

Job angesehen

Tippen Sie erneut, um zu schließen

Arbeitsbeschreibung

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at Function:**
Quality
**Job Sub** **Function:**
Quality Assurance
**Job Category:**
Professional
**All Job Posting Locations:**
Schaffhausen, Switzerland
**Job Description:**
**Specialist QA Aseptic Expert & Oversight, 80-100%, on-site**
**Zu den Haupttätigkeiten gehören unter anderem:**
+ Quality Oversight des aseptischen Produktionsbereichs vor Ort mit Fokus auf: aseptische Prozesse, Umgebungs- und Utilitiesmonitoring, Verhalten im Reinraum, Einkleiden und Desinfektion sowie Unterstützung in anderen Bereichen
+ Zeitgerechte Auswertung von Beobachtungen im Rahmen der Quality Oversight
+ Verantwortlichkeit für Qualifizierung von Mitarbeitern im aseptischen Bereich
+ Identifizierung von Risiken sowie Verbesserungspotentialen im aseptischen Bereich hinsichtlich Kontaminationskontrolle und aktive Umsetzung entsprechender Initiativen in enger Zusammenarbeit mit der Produktion, Qualitätsabteilung und dem Management
+ Kontrolle und Sicherung der Prozesse in der Pharmaproduktion unter Einhaltung aller GMP-relevanten Weisungen und Vorschriften
+ Koordination und Mithilfe bei der Analyse und Dokumentation von Abweichungen
+ Koordination und Mithilfe bei der Festlegung und Umsetzung korrigierender Massnahmen
+ Erstellung, Bearbeitung und Approval von Dokumenten (z.B. SOPs, WIs, MBRs) im TruVault-System
**Wen wir suchen:**
+ Berufsausbildung oder mehrjährige Erfahrung in der Pharma- oder Lebensmittelindustrie
+ Kenntnisse der aseptischer Herstellung ist eine Voraussetzung
+ Schichtarbeit im 3-Schichtbetrieb
+ Bereitschaft zu gelegentlichen Wochenendeinsätze
+ Pro-Aktive und exakte Arbeitsweise
+ Sehr gute Kommunikationsfähigkeiten
+ Team Player
+ Gute IT-Anwenderkenntnisse
+ Sehr gute Deutschkenntnisse
+ Grundlegende Englischkenntnisse in Wort und Schrift
Wenn Sie sich für diese spannende Aufgabe in einem international führenden Gesundheitsunternehmen interessieren, freuen wir uns auf Ihre vollständige Bewerbung!
Leider ist dieser Job in Ihrer Region nicht verfügbar
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Manager - Clinical Budget Development

Schaffhausen, Schaffhausen AbbVie

Vor 2 Tagen gepostet

Job angesehen

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Arbeitsbeschreibung

Company Description
AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas - immunology, oncology, neuroscience, and eye care - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok ( .
Job Description
The Manager of Global Clinical Budget Development reports to the Associated Director and who works under limited supervision and guidance. This position serves as a subject matter expert in the clinical trial budget development space. Candidate will frequently interact interdepartmentally with R&D, Purchasing and Supply Management (PSM) and Finance business teams/functional areas including Study Forecasters/Financial Analysts, Legal, Clinical Payments, and Global Clinical Site Contracting teams for clinical study budget development. The Manager of Global Clinical Budget Development is also expected to identify and resolve issues that arise to ensure budgets are compliant with study protocol requirements, are aligned with overall study budget projections and consistent with the Fair Market Value (FMV) benchmarking tool (GrantPlan) pricing and thus reflecting the overall financial requirements to support AbbVie's clinical trials.
Responsibilities:
+ Provides operational expertise and strategic leadership, support, guidance, and training to teams on all aspects of global clinical budget development.
+ Influences and efficiently partners with AbbVie R&D to build global clinical site study budgets in compliance with all applicable policies, procedures, and objectives.
+ May assist in leading and managing the clinical budget analyst staff, including, but not limited to the workload management, quality of deliverables and escalation of issues to management when needed.
+ Develop, maintain, and train stakeholders on the use of the global budget development documents, including the Exhibit A and other Fair Market Tool Assessments, Act as the first line of contact to stakeholder to provide strategic insight, when required, into budget building process with difficult protocol situations (i.e., complex clinical protocols, difficult therapeutic areas with high priority studies).
+ Independently creates global and country specific clinical trial budget templates, FMV benchmarks, etc. using clinical budgeting tools and systems (i.e., GrantPlan, Conga, SharePoint etc.)
+ Actively and effectively communicates status of budget build with key internal and external stakeholders in a timely manner. Communicates issues to stakeholders that could impact project timelines or other aspects for study start-up.
+ Closely works with Clinical Development Operations (CDO) Study Project Manager (SPM), Study Management Associate (SMA), Project Lead (PL), Therapeutic Area Medical Director's (TAMD), Legal, Outside United States (OUS), Contract Managers (CM), Payments, to mitigate, and resolve budget and/or FMV issues as they arise during any point in the clinical trial. Lead Clinical Study Agreement (CSA) Budget Strategy calls and present at Study Kick-off Meetings with cross-functional team members.
+ Develops the most current and transparent budget that is also in-line with industry standards. Serve as a subject matter expert in medical/CPT code competencies across multiple therapeutic/functional areas.
+ Applies United States Medicare Coverage Analysis (MCA) guidelines for applicable therapeutic areas and have a solid understanding of MCA requirements. Able to analyze budgets and identify cost drivers where applicable.
+ Ability to review and analyze complex protocol amendments and decide budget impact and will work with SPMs, OUS, and CMs to be agile in determining the impact of the protocol and if the changes constitute in a budget amendment. Identify and participate in ongoing process improvement initiatives when appropriate (i.e., Budget Innovation Tool (BIT), new templates/processes etc.).
Qualifications
Minimum Qualifications:
+ BA/BS is required
+ Expertise with Excel is required.
+ Minimum of 4 years of related job experience with 2 years of clinical budget experience
Preferred Qualifications:
+ Science degree is preferred
+ Clinical research experience is highly desirable.
+ Expertise with clinical cost benchmarking tools and/or ICD-9/10 and CPT codes is highly preferred
+ Clinical budget experience in a scientific setting is highly preferred.
+ Customer support focused expertise is highly desirable.
Other Required Skills:
+ Must have demonstrated ability in negotiation skills, project management skills and effective communication and relationship management abilities.
+ Must have extreme attention to detail along with an understanding of the quality/compliance environment.
+ Ability to sustain high levels of performance in a constantly changing environment.
+ Proven experience in managing all levels of key internal and external stakeholders effectively by frequently soliciting input and gathering and incorporating feedback into process improvements as appropriate.
+ Hybrid model 3 days/week onsite.
Additional Information
AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community.  Equal Opportunity Employer/Veterans/Disabled.
US & Puerto Rico only - to learn more, visit & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:
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MSAT Biotherapeutics DP, Tech Transfer Lead

Schaffhausen, Schaffhausen J&J Family of Companies

Vor 4 Tagen gepostet

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Arbeitsbeschreibung

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at Function:**
Supply Chain Engineering
**Job Sub** **Function:**
Process Engineering
**Job Category:**
Scientific/Technology
**All Job Posting Locations:**
Schaffhausen, Switzerland
**Job Description:**
**Johnson & Johnson**
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at .
**Introduction and Overview**
Cilag GmbH International, a member of the Johnson & Johnson Family of Companies, is recruiting for a Technical Launch Integrator - Principal Scientist; MSAT Biotherapeutics Drug Product Launch & Grow (Bio DP L&G).
The Technical Launch Integrator (TLI) has overall accountability for ensuring fit for plant and commercial readiness during technical development, including implementation of new innovations & technologies. The TLI is also responsible for the execution of the transfer of pharmaceutical processes and products into the supply chain and the global marketplace, as well as site-to-site transfers keeping the Best Process/Product at Launch (BPAL) mindset. Areas of key functions include DP technical support and oversight for supply chain, planning and execution of DP manufacturing site level support of new product launch.
**Objectives** **of the Position**
+ Technical and manufacturing integration of new and re-developed drug products from R&D into the supply chain while using new innovations & technologies keeping the Best Process/Product at Launch (BPAL) mindset.
+ Contribution, review, and approval of drug product technical and regulatory documents, routine technical support, integration of supply chain technical expertise into project execution, and Quality by Design (QbD) technical implementation at the manufacturing site level.
+ Single point of contact for supply plant readiness and execution and launch support between the Development and Commercial supply chain organizations.
+ Identify and implement opportunities for active decrease of COGs and partner with Development and supply chain groups to implement strategies to improve process robustness, fit for plant, and commercialization of new products into the supply chain.
+ Develop the manufacturing site execution plan per product, in line with the overall strategy and plan as outlined by the relevant cross-functional teams; ensure alignment and endorsement of this strategy within the manufacturing site and TLI function.
+ Coordinate and implement product introduction at the site from transfer through launch covering raw materials, formula, process, packaging, and device integration into the finished product.
+ Optimize the NPI process, make use of technology platforms, accelerate development timelines, and streamline the technical transfer process.
**What you will need to succeed**
Ability to foster team efficiency and cohesiveness and to work collaboratively to implement, deliver and get results through the various matrix teams, and influence with or without direct authority.
Motivated, self-starter able to work independently with proven problem-solving skills.
**Qualifications:**
+ Minimum of a Bachelor's/University or equivalent degree (required). M.S. or PhD (preferred).
+ Minimum 6 years of relevant work experience with pharmaceutical product R&D and/or Manufacturing / MSAT functions, or equivalent (required).
+ Experience with technical transfer of biopharmaceutical products into manufacturing sites, including technical knowledge of DP unit operations (required).
+ Knowledge of manufacturing site systems and procedures, including an understanding of GMP requirements (required).
+ Knowledge of DP late-stage development (preferred).
+ Knowledge in ADCs (preferred).
+ Experience with document management systems such as RIMdocs, TruVault, SAP, MS Office applications, Comet, and/or Planisware (preferred).
+ FPX, PMP, or equivalent Project Management certification (preferred).
+ Proficient in English (required) and German (preferred) language.
+ May require up to 20% domestic and international travel, depending on project needs.
**Application**
Are you interested in joining a team that is passionate about groundbreaking biomedicine operations that positive improve the lives of patients? Do you want to work for an employer with an excellent record in employee continuous professional development and business improvement? Apply today to J&J! please apply with an updated CV and Cover letter in English. The selection process will start during the posting period, please send in your application as soon as possible. We reserve the rights to close the advert earlier. All applicants can expect feedback on the application.
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Technical Product Owner

Schaffhausen, Schaffhausen J&J Family of Companies

Vor 5 Tagen gepostet

Job angesehen

Tippen Sie erneut, um zu schließen

Arbeitsbeschreibung

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at Function:**
Technology Product & Platform Management
**Job Sub** **Function:**
Technical Product Management
**Job Category:**
People Leader
**All Job Posting Locations:**
Schaffhausen, Switzerland
**Job Description:**
We are searching for the best talent for a **Technical Product Owner** who will lead and support manufacturing site technology solutions from an IT perspective. This role involves managing individual contributors and vendors, developing tactical and operational plans, to support organizational objectives and business goals. The Technical Product Owner will develop roadmaps aligning with strategic technology programs and business needs.
The location for this position is **Schaffhausen - Switzerland** and requires a minimum of 3 days on site per week.
**You will be responsible for**
+ Allocates resources to create solutions to business problems and outlines the solutions via clear and executable product requirements. Focuses and prioritizes the team's execution on the most business-critical problems.
+ Manages individual contributors and vendors. Develops tactical and operational plans to achieve site specific Technology Product & Platform Management goals and communicates plans to managers, supervisors, and individual contributors.
+ Product budgets from financing to implementation.
+ Supports technology strategy for business partners and develops roadmaps.
+ Develops insights for site leadership. Contributes to technology projects, programs, and processes. Creates reports, visualizations or other documents. Presents findings and provides updates on status to team and management.
**Required qualifications**
+ Bachelor's degree
+ A minimum of 5 years experience in a similar position
+ Experience in leading and managing vendors
+ Strong understanding of GMP, EHS and SOX requirements
+ Experience in a (pharmaceutical) manufacturing environment
+ Fluent in German and English
+ Substantial skills in relevant technologies (Digital and Innovation)
+ Focus on Business agility and challenge thinking
At Johnson & Johnson, we're on a mission to change the trajectory of health for humanity. That starts by creating the world's healthiest workforce. Through programs and policies, we empower the physical, mental, emotional and financial health of our employees and the ones they love.
Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.
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