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Associate Director / Head of QA Qualification, CAPEX Project 80-100%

4332 Stein, Aargau Lonza

Gestern

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Arbeitsbeschreibung

fulltime, freelancer

Location: Stein AG (Switzerland)

Relocation assistance is available for eligible candidates and their families, if needed.

Today, Lonza is a global leader in life sciences operating across five continents. While we work in science, there’s no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big and small, genuinely improve the world. And that’s the kind of work we want to be part of.

Are you prepared to lead and have an impact in the life sciences industry? Lonza AG is searching for an outstanding candidate for the position of Associate Director / Head of QA Qualification, CAPEX Project in Switzerland. This is an outstanding chance to lead the quality oversight during the critical Commissioning & Qualification phases of GMP-relevant systems in the scope of a large capital investment project. Join us in our ambitious mission to deliver world-class scientific solutions!

What you’ll get:

  • An agile career and dynamic working culture

  • An inclusive and ethical workplace

  • Compensation programs that recognize high performance

  • Along with competitive salaries, you’ll find a wide range of lifestyle, family and leisure benefits available. The full list of our local benefits can be also found on assetstream.aspx

What you’ll do

  • Leadership: Train, supervise, and guide the QA Engineering Team to ensure flawless execution of Capex project and being right first time in compliance.

  • Supervise the quality and compliance duties across diverse project phases, from Commissioning and Qualification (C&Q) to the handover to Operations.

  • Verify that Direct Impact Systems (such as facilities, equipment, utilities, and computerized systems) are qualified for their intended use by meeting Lonza's standards and regulatory requirements.

  • Manage Quality Risks and compliance gaps to minimize the impact of potential quality issues and ensure regulatory compliance.

  • Provide leadership and guidance on C&Q documentation, including DQ, FAT/SAT, IV, OFT, IQ, OQ, and QR.

  • Assist with the progression of project stages from planning and C&Q execution to the handover to Operations and Inspection Readiness.

  • Work together with the Project Leadership Team to guarantee synchronization of the project implementation strategy and attain quality and compliance objectives.

What we’re looking for:

  • University degree in life sciences or engineering, or equivalent experience.

  • Proven experience as Project Quality Lead, experience in lifecycle qualification, experience in leading/managing a CAPEX project, or prior MSAT experience is a must.

  • Experience in aseptic/sterile manufacturing (EU Annex 1) is a must .

  • Experience in commissioning, qualification & validation (EU Annex 15) is a must (practical hands-on experience is a plus)

  • Direct line team lead experience is a must

  • Proficient in English; Knowledge of German is a bonus.

Join Lonza AG and be part of an environment where your expertise is valued, and your career can flourish. We look forward to welcoming you to our team!

Every day, Lonza’s products and services have a positive impact on millions of people. For us, this is not only a great privilege, but also a great responsibility. How we achieve our business results is just as important as the achievements themselves. At Lonza, we respect and protect our people and our environment. Any success we achieve is no success at all if not achieved ethically.

People come to Lonza for the challenge and creativity of solving complex problems and developing new ideas in life sciences. In return, we offer the satisfaction that comes with improving lives all around the world. The satisfaction that comes with making a meaningful difference.

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Betriebs-/Anlagemeister in der pharmazeutischen Industrie 80-100% (m/w/d)

3930 Visp, Wallis Lonza

Vor 2 Tagen gepostet

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Arbeitsbeschreibung

fulltime, freelancer

Lonza ist heute ein weltweit führendes Unternehmen im Bereich Life Sciences, welches auf drei Kontinenten tätig ist. Wir sind in der Wissenschaft tätig, jedoch gibt es keine Zauberformel dafür, wie wir die Arbeit angehen. Unsere wichtigste wissenschaftliche Lösung sind talentierte Mitarbeitende, die zusammenarbeiten und Ideen entwickeln, die anderen Unternehmen helfen, Menschen zu helfen. Im Gegenzug steuern unsere Mitarbeitenden ihre Karriere selbstständig. Denn ihre Ideen, ob gross und klein, verbessern die Welt. Und das ist die Art von Arbeit, an der wir Teil haben möchten.

Als Betriebs-/Anlagemeister (m/w/d) sind Sie zuständig für die technische und logistische Abwicklung von Produktionskampagnen in einem Produktionsbetrieb zur Herstellung von Biokonjugaten. Sie sind Mitglied eines interdisziplinären Teams und arbeiten in Projektteams mit, welche sich um Investitionen sowie Optimierungen von Abläufen, Tätigkeiten und Systemen kümmern.

Ihre Aufgaben:

  • Einbringung in Planungs- und Engineering Phase von Projekten, um technische Vorgaben für die Anlagen einzuhalten und eine erfolgreiche Produktionskampagne sicherzustellen

  • Organisatorische und betriebstechnische Betreuung, sowie Überwachung der Produktionskampagnen, zur Sicherstellung der Produktion und Sicherheit auch ausserhalb der normalen Arbeitszeit

  • Erstellung von cGMP gerechter Dokumentation in Zusammenarbeit mit dem Anlageteamleiter, der Forschung/Entwicklung und den Betriebsbiotechnologen

  • Anlagetechnische Instruktion und produktionsspezifische Ausbildung der Operatoren während der Produktion

  • Kontrolle der lückenlosen Befolgung der Betriebsvorschriften und Herstellungsprotokolle, sowie Eingriff bei Abweichungen

  • Unterstützung des Informationsaustausches und Kommunikation innerhalb der Betriebsgruppe

  • Durchgehende Verbesserung von Anlagen, Abläufen und Prozessen (6S, Lean Six Sigma, KAIZEN) unter Einhaltung der Sicherheits-, Hygiene-, Umwelt- und Qualitätsanforderungen

Ihr Anforderungsprofil:

  • Abgeschlossene technische Aus- oder Weiterbildung (Berufslehre, Höhere Fachprüfung, Bachelor, Master)

  • Vorteilhaft wäre Produktionserfahrung bei der Herstellung von chemischen oder biotechnologischen Produkten, oder in der Lebensmittelindustrie

  • Idealerweise erste Erfahrung im ISO- und / oder GMP-Produktionsumfeld

  • Sie verfügen über Grundkenntnisse in MS Office (Excel, Word) und sind affin für elektronische Systeme und Anwendungen

  • Sehr gute Deutschkenntnisse in Wort und Schrift, sowie Englischkenntnisse

  • Bereitschaft zur Leistung von Pikettdienst muss vorhanden sein

Umzugsunterstützung für berechtige Kandidaten wird bereitgestellt.

Lonzas Produkte und Services wirken sich täglich positiv auf Millionen von Menschen aus. Für uns stellt dies nicht nur eine grosse Ehre, sondern auch eine grosse Verantwortung, dar. Wie wir unsere Geschäftsergebnisse erreichen ist für uns genauso wichtig wie unsere Erfolge selbst. Bei Lonza wird Respekt grossgeschrieben und wir schützen sowohl unsere Mitarbeiter als auch unsere Umwelt. Erfolg für uns bedeutet moralisch vertretbarer Fortschritt.

Zu Lonza kommen Menschen, die Herausforderungen annehmen und mit ihrer Kreativität im Bereich Life Science neue Ideen für komplexe Problemstellungen entwickeln. Zusammen leisten wir einen Beitrag, der das Leben vieler Menschen auf der ganzen Welt verbessern kann. Dies bietet ihnen die Gewissheit und die Zufriedenheit, mit der eigenen Arbeit wirklich einen Unterschied zu machen.

Leider ist dieser Job in Ihrer Region nicht verfügbar

Head of EHS Advanced Synthesis 80-100% (m/f/d)

3930 Visp, Wallis Lonza

Vor 5 Tagen gepostet

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Arbeitsbeschreibung

fulltime, freelancer

Today, Lonza is a global leader in life sciences operating across five continents. While we work in science, there’s no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big and small, genuinely improve the world. And that’s the kind of work we want to be part of.

The actual location of this job is in Visp, Switzerland. Relocation assistance is available for eligible candidates and their families, if needed.

We are looking for a visionary Head of EHS – Advanced Synthesis to join our Visp site and drive the strategic integration of Environment, Health & Safety across a dynamic, global business platform. In this key leadership role, you will shape a proactive safety culture, ensure regulatory compliance, and lead a team of EHS and process safety experts.

This is a unique opportunity for an experienced leader with a strong background in chemical or pharmaceutical manufacturing, who thrives in complex environments and wants to make a lasting impact on safety performance worldwide. If you're ready to combine EHS excellence with innovation and global collaboration—this role is for you.

Key Responsibilities

  • Act as the lead EHS contact for the Visp site and provide expert support to our site in Nansha (China).

  • Develop and implement EHS strategies to ensure regulatory compliance and operational excellence.

  • Lead a team of EHS professionals and drive cross-site alignment of safety programs and practices.

  • Represent EHS at senior leadership level and cultivate a strong safety culture throughout the organization.

  • Coordinate incident investigations, risk assessments, and continuous improvement initiatives.

  • Ensure effective communication and collaboration between site, platform, and corporate EHS functions.

Requirements
  • University degree or equivalent experience in Engineering, Chemistry, Occupational Safety, or a related technical field; advanced degree preferred.

  • Extensive EHS leadership experience in the chemical or pharmaceutical industry.

  • Deep knowledge of process safety, explosion protection, and industrial risk management.

  • Established proficiency in guiding teams, engaging partners, and inspiring change in a matrixed organization.

  • Strategic, analytical approach with strong communication skills.

  • Proficient in English; German is a strong asset.

Every day, Lonza’s products and services have a positive impact on millions of people. For us, this is not only a great privilege, but also a great responsibility. How we achieve our business results is just as important as the achievements themselves. At Lonza, we respect and protect our people and our environment. Any success we achieve is no success at all if not achieved ethically.

People come to Lonza for the challenge and creativity of solving complex problems and developing new ideas in life sciences. In return, we offer the happiness that comes with improving lives all around the world. The happiness that comes with making a meaningful difference.

Lonza is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a qualified individual with disability, protected veteran status, or any other characteristic protected by law.

Leider ist dieser Job in Ihrer Region nicht verfügbar

MSAT Validation Specialist (f/m/d) 80-100%

3930 Visp, Wallis Lonza

Vor 5 Tagen gepostet

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Arbeitsbeschreibung

fulltime, freelancer

The actual location of this job is in Visp, Switzerland. Relocation assistance is available for eligible candidates and their families, if needed.

Today, Lonza is a global leader in life sciences operating across five continents. While we work in science, there’s no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big and small, genuinely improve the world. And that’s the kind of work we want to be part of.

The site in Visp, Switzerland is growing and for our Bioconjugates organization, we are currently looking for MSAT Process Validation Specialist (80-100%). In this role, you will be responsible for manufacturing process validation in the biopharmaceutical plants, including process characterization, validation activities at scale and Product Quality Reviews (PQRs). Are you ready to join this outstanding team? Apply now!

What you’ll get:

  • An agile career and dynamic working culture

  • A highly collaborative environment that fosters teamwork and inclusion

  • A range of professional development programs to grow your skills and career

  • An ethical workplace where tasks are carried out in accordance to the relevant procedures

  • Compensation programs that recognize high performance

What you'll do:

  • Prepare validation documents (study design / writing protocols and reports) according to Lonza procedure and in compliance with regulatory guidance.

  • Own the process validation including communication with customers.

  • Review and approving of process characterization documents.

  • Responsible for the validation assessment on changes and deviations (approval of deviation and changes).

  • Prepare and maintain a documented continued process verification plan.

  • Authoring, a ssessing and approving of PQRs

What we're looking for:

  • Master or Ph.D in Chemistry, Biotechnology, Life Sciences or related field, or equivalent experience

  • Experience in project management, preferable in MSAT, Operation, Quality and Compliance.

  • Experience in interaction with different teams within an organization and with regulatory agencies (Swissmedic, FDA etc.) would be an advantage.

  • Ability to work on different tasks simultaneously and in a timely manner.

Every day, Lonza’s products and services have a positive impact on millions of people. For us, this is not only a great privilege, but also a great responsibility. How we achieve our business results is just as important as the achievements themselves. At Lonza, we respect and protect our people and our environment. Any success we achieve is no success at all if not achieved ethically.

People come to Lonza for the challenge and creativity of solving complex problems and developing new ideas in life sciences. In return, we offer the satisfaction that comes with improving lives all around the world. The satisfaction that comes with making a meaningful difference.

Lonza is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a qualified individual with disability, protected veteran status, or any other characteristic protected by law.

Leider ist dieser Job in Ihrer Region nicht verfügbar

Operator Bioconjugates IBEX (m/f/d)

3930 Visp, Wallis Lonza

Vor 5 Tagen gepostet

Job angesehen

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Arbeitsbeschreibung

fulltime, freelancer

The actual location of this job is in Visp, Switzerland. Relocation assistance is available for eligible candidates and their families, if needed.

Today, Lonza is a global leader in life sciences operating across five continents. While we work in science, there’s no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big and small, genuinely improve the world. And that’s the kind of work we want to be part of.

In order to support our continued growth Lonza is seeking Operators to join our talent community. Are you thinking about a career change? Become part of this exciting opportunity and join our outstanding team! Apply now as Operator BioConjugates!

What You'll get:

  • An agile career and a dynamic work culture

  • An inclusive and ethical workplace

  • Compensation programs that recognize high performance

  • A 6-week training program for career changer

What You'll Do:
  • Independent operation of familiar parts of the production plant in accordance with specification documents (manufacturing protocols / operating instructions / work instructions / SOP)

  • Safe and accurate execution of work in compliance with safety regulations and cGMP quality requirements

  • Responsibility for cleanliness and order in the workplace as well as the assigned rooms and warehouses

  • Every operator in the Ibex operation is involved as an equal team member through active assistance in continuous improvement processes

What we're looking for:
  • Vocational training (EFZ) or Education in Chemical, Biology or Pharmaceutical technology or proven experience

  • Meticulous and documentation skills

  • Carrying out work with a high level of safety awareness

  • Willingness to work in shifts (4-shift operation) with flexibility in work scheduling

  • Proficient in German and/or English

  • Knowledge of DeltaV or MES, as well as experience in GMP, is an asset

Every day, Lonza’s products and services have a positive impact on millions of people. For us, this is not only a great privilege, but also a great responsibility. How we achieve our business results is just as important as the achievements themselves. At Lonza, we respect and protect our people and our environment. Any success we achieve is no success at all if not achieved ethically.

People come to Lonza for the challenge and creativity of solving complex problems and developing new ideas in life sciences. In return, we offer the satisfaction that comes with improving lives all around the world. The satisfaction that comes with making a meaningful difference.

Lonza is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a qualified individual with disability, protected veteran status, or any other characteristic protected by law.

Leider ist dieser Job in Ihrer Region nicht verfügbar

Teamleiter - Automatik (m/w/d)

3930 Visp, Wallis Lonza

Vor 5 Tagen gepostet

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Arbeitsbeschreibung

fulltime, freelancer

Lonza ist heute ein weltweit führendes Unternehmen im Bereich Life Sciences, welches auf drei Kontinenten tätig ist. Wir sind in der Wissenschaft tätig, jedoch gibt es keine Zauberformel dafür, wie wir die Arbeit angehen. Unsere wichtigste wissenschaftliche Lösung sind

Als Teamleiter EMR (m/w/d) übernehmen Sie gemeinsam mit Ihrem Team eine zentrale Rolle im Bereich der Mess-, Steuer- und Regeltechnik (EMR) sowie der Automatisierung. Ihr Aufgabenbereich umfasst die Planung, Koordination und Überwachung von Instandhaltungs- und Optimierungsmassnahmen an Produktionsanlagen. Dabei stellen Sie die Einhaltung von Sicherheits- und Qualitätsstandards sicher und fördern die kontinuierliche Weiterentwicklung technischer Abläufe. Durch die enge Zusammenarbeit mit anderen Fachbereichen leisten Sie einen wichtigen Beitrag zur Erhöhung der Anlagenverfügbarkeit und betrieblichen Effizienz.

Ihre Aufgaben:

  • Fachliche und personelle Führung des Automatik-Teams innerhalb der EMR-Werkstatt (20–25 Mitarbeitende)

  • Planung von Kalibrierarbeiten

  • Inbetriebnahmen, Wartungen und Störungsbehebungen an sämtlichen Waagen im gesamten Werk

  • Instandhaltungs- und Störungsdienstleistungen im Bereich der werksweiten Infrastruktur (SI)

  • Organisation und Koordination der EMR-Schicht sowie des Pikettdienstes im Werk Visp

  • Mitverantwortung für die Aus- und Weiterbildung Ihres Teams und Förderung der individuellen Entwicklung der Mitarbeitenden

Ihr Profil:

  • Abgeschlossene Berufsausbildung als Elektroinstallateur EFZ, Automatiker EFZ oder Elektroniker EFZ

  • Mehrjährige Berufserfahrung im Bereich Elektrotechnik, Automatisierung oder verwandten Fachgebieten

  • Weiterbildung auf Stufe höhere Fachprüfung in Elektrotechnik oder Automation von Vorteil

  • Führungserfahrung in einer vergleichbaren Position mit nachweisbarer Fähigkeit, Teams zu motivieren und weiterzuentwickeln

  • Hohes Mass an Selbstständigkeit, Eigenverantwortung und unternehmerischem Denken

  • Offenheit für neue Technologien und Bereitschaft zur kontinuierlichen fachlichen Weiterbildung

  • Ausgeprägte Teamfähigkeit, Kommunikationsstärke und eine klare, lösungsorientierte Ausdrucksweise

Umzugsunterstützung steht berechtigen Kandidaten und ihren Familien bei Bedarf zur Verfügung.

Lonzas Produkte und Services wirken sich täglich positiv auf Millionen von Menschen aus. Für uns stellt dies nicht nur eine grosse Ehre, sondern auch eine grosse Verantwortung, dar. Wie wir unsere Geschäftsergebnisse erreichen ist für uns genauso wichtig wie unsere Erfolge selbst. Bei Lonza wird Respekt grossgeschrieben und wir schützen sowohl unsere Mitarbeiter als auch unsere Umwelt. Erfolg für uns bedeutet moralisch vertretbarer Fortschritt.

Zu Lonza kommen Menschen, die Herausforderungen annehmen und mit ihrer Kreativität im Bereich Life Science neue Ideen für komplexe Problemstellungen entwickeln. Zusammen leisten wir einen Beitrag, der das Leben vieler Menschen auf der ganzen Welt verbessern kann. Dies bietet ihnen die Gewissheit und die Zufriedenheit, mit der eigenen Arbeit wirklich einen Unterschied zu machen .

Leider ist dieser Job in Ihrer Region nicht verfügbar

Senior MSAT (Manufacturing Science & Technology) Expert - Drug Product, Greenfield Project 80-100%

4332 Stein, Aargau Lonza

Vor 5 Tagen gepostet

Job angesehen

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Arbeitsbeschreibung

fulltime, freelancer

Location: Stein (Switzerland)

Relocation assistance is available for eligible candidates and their families, if needed.

Today, Lonza is a global leader in life sciences operating across five continents. While we work in science, there’s no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big and small, genuinely improve the world. And that’s the kind of work we want to be part of.

Become a Senior MSAT Expert at Lonza AG for an exciting Greenfield project in Stein AG Switzerland! Support the commercial readiness of a large-scale aseptic manufacturing facility for Biologics.

What you’ll get:
  • An agile career and dynamic working culture

  • An inclusive and ethical workplace

  • Compensation programs that recognize high performance

  • Along with competitive salaries, you’ll find a wide range of lifestyle, family and leisure benefits available. The full list of our local benefits can be also found on assetstream.aspx

Key responsibilities:
  • Act as the MSAT expert in capital investment projects to build and commission manufacturing units, ensuring commercial readiness for the GMP manufacturing facility.

  • Define qualification strategies and concepts for DP manufacturing equipment and clean rooms in alignment with regulatory requirements (e.g EU GMP, FDA, ICH). Lead and act as a MSAT member in cross-functional project teams (e.g QA, Engineering, Manufacturing, QC).

  • Provide technical leadership during the design of the sterile manufacturing processes, including cleanroom layout, material/personnel flow, and equipment placement.

  • Craft the Aseptic Process Simulation concept in alignment with internal guidelines and regulatory requirements. Provide oversight and technical support during execution of APS and all investigations regarding the aseptic manufacturing process. Support the development of aseptic technique training programs.

  • Lead risk assessments (e.g FMEA) to identify critical manufacturing process parameters and control strategies for the facility. Author and review GMP documents such as Qualification/Validation master plans, protocols and reports, SOPs, manufacturing concepts, etc.

  • Ensure GMP documentation readiness for authority inspections in line with internal and external quality standards.

  • Contribute to the development and implementation of standardized MSAT procedures and processes, including qualification standards, single-use systems, and filtration systems.

Key requirements:
  • University Degree or equivalent technical education in Biotechnology, Pharmacy, or a related field.

  • Significant experience in sterile drug product manufacturing in a GMP environment is a must, with substantial know-how in aseptic processing and sterility assurance principles.

  • Experience in qualification of manufacturing equipment, cleaning validation, and room qualification is an asset.

  • Strong communication skills, able to translate complex technical topics into clear actionable messages.

  • Proactive, positive approach, problem-solving attitude, and ability to take full responsibility for assigned areas.

  • Ability to lead cross-functional teams and drive decision-making in a matrix organization; build strong networks and trust across internal and external stakeholders.

  • Proficiency in English is a must; German language skills are a plus.

We are looking for someone who can find the best scientific solutions and efficiently implement them in real-world scenarios. If you are ready to collaborate at an outstanding level and deliver magnificent results, we would love to hear from you!

Lonza is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a qualified individual with disability, protected veteran status, or any other characteristic protected by law.

Every day, Lonza’s products and services have a positive impact on millions of people. For us, this is not only a great privilege, but also a great responsibility. How we achieve our business results is just as important as the achievements themselves. At Lonza, we respect and protect our people and our environment. Any success we achieve is no success at all if not achieved ethically.

People come to Lonza for the challenge and creativity of solving complex problems and developing new ideas in life sciences. In return, we offer the satisfaction that comes with improving lives all around the world. The satisfaction that comes with making a meaningful difference.

Leider ist dieser Job in Ihrer Region nicht verfügbar

Head QA, manufacturing equipment qualification CQV 80-100%

4332 Stein, Aargau Lonza

Vor 5 Tagen gepostet

Job angesehen

Tippen Sie erneut, um zu schließen

Arbeitsbeschreibung

fulltime, freelancer

Location: Stein (Switzerland)

Relocation assistance is available for eligible candidates and their families, if needed.

Today, Lonza is a global leader in life sciences operating across five continents. While we work in science, there’s no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big and small, genuinely improve the world. And that’s the kind of work we want to be part of.

Are you looking for a unique opportunity to integrate a Greenfield project (building several new production lines) into the existing manufacturing environment? As Head Quality CQV you will be part of the Site Quality Leadership team, shaping the quality landscape at Lonza AG in Stein!

What you’ll get:
  • An agile career and dynamic working culture

  • An inclusive and ethical workplace

  • Compensation programs that recognize high performance

  • Along with competitive salaries, you’ll find a wide range of lifestyle, family and leisure benefits available. The full list of our local benefits can be also found on assetstream.aspx

Key responsibilities:
  • Establish and maintain the Equipment Qualification System at Lonza Drug Product Services (DPS), including the commissioning, process and computerized systems validation, qualification of manufacturing equipment.

  • Lead and develop a team of QA Experts, guiding them in line with Lonza’s values and behaviors, including objective setting, performance evaluations, development planning, and participation in the recruiting process. Support a culture of high performance and trust, ensuring the required level of knowledge and skills are available and identifying proficiency gaps

  • Ensure accurate qualification of equipment, infrastructure, and computerized systems by adhering to corresponding VMP(s). Support and ensure the implementation of global procedures related to CQV. Serve as the first contact for overarching documents related to equipment, infrastructure, and computerized systems qualification & maintenance within QA.

  • Supervise compliance activities such as GMP status and trending of equipment, qualification/re-qualification in relation to supplier qualification, changes, nonconformities, CAPAs, audit/inspection/self-inspection observations, and document management

  • Collaborate with other sites and global teams to improve and align CQV processes within Lonza. Ensure decisions are fully supported by global and local Quality and Regulatory standards

  • Ensure effective use of resources (budget, time, personnel, systems)

  • Coordinate the qualification of equipment suppliers/services by supervising adherence to quality agreements and audit observations. Track GMP status of service providers, including calibration, maintenance, and consultants

Key requirements:
  • Degree or equivalent experience in Life Science, Engineering, or a related field

  • Several years of leadership experience is a prerequisite

  • Work experience in Quality Assurance

  • Solid experience in qualification topics within the pharmaceutical, GMP-controlled sterile manufacturing area, including solid CQV experience is crucial

  • Experience with audits, including being part of the front office is a must; experience specifically with Swissmedic is an advantage

  • Demonstrated assertiveness to uphold quality standards and make decisive calls in fast-paced environments with opposing priorities

  • Proficiency in English is a must; language skills in German are a plus

Lonza is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a qualified individual with disability, protected veteran status, or any other characteristic protected by law.

Every day, Lonza’s products and services have a positive impact on millions of people. For us, this is not only a great privilege, but also a great responsibility. How we achieve our business results is just as important as the achievements themselves. At Lonza, we respect and protect our people and our environment. Any success we achieve is no success at all if not achieved ethically.

People come to Lonza for the challenge and creativity of solving complex problems and developing new ideas in life sciences. In return, we offer the satisfaction that comes with improving lives all around the world. The satisfaction that comes with making a meaningful difference.

Leider ist dieser Job in Ihrer Region nicht verfügbar

Associate Director, GE Commissioning and Qualification (CQ) (80-100%) (m/w/d)

4332 Stein, Aargau Lonza

Vor 5 Tagen gepostet

Job angesehen

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Arbeitsbeschreibung

fulltime, freelancer

A Career at Lonza

What you’ll get

  • An agile career and a dynamic work culture

  • An inclusive and ethical workplace

  • Compensation programs that recognize high performance

  • In addition to a competitive salary, you can expect numerous lifestyle, family, and leisure benefits. Benefits in Stein:

Today, Lonza is a global leader in life sciences operating across five continents. While we work in science, there’s no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big and small, genuinely improve the world. And that’s the kind of work we want to be part of.

We are hiring for a driven Global Engineering CQ Lead Shared Function (Commissioning, Qualification). In this role you will ensure that services and processes meet the regulatory requirements and quality standards.

Join our ambitious team and help deliver world-class engineering projects. This is an outstanding opportunity to contribute to innovative CQ projects in Switzerland !

The role is based in Stein, Switzerland. Relocation assistance is available for eligible candidates and their families, if needed. This role involves being onsite full time.

What you'll do:

  • Responsible for handling and leading a team of CQ experts.

  • Oversee the generation of all protocols for several projects such as life cycle documents.

  • Commissioning and qualification plan and report.

  • Oversee the alignment and execution of the IV/IQ static testing across all site projects.

  • The GE CQ Lead shared function will mainly support all the CQ Portfolio lead but also collaborates with other departments, such as engineering, manufacturing, quality, procurement and regulatory affairs, to ensure that CQ activities are increasing on efficiency regarding Cost and Timeline.

  • Oversee several remote offices which will be located in different strategic locations across the globe to increase efficiency and to reduce cost. ·

  • Be in charge to assess the capability and capacity of all suppliers quality department to ensure delivery of proper documentation in timely manner.

  • Lead CQV activities to ensure compliance with regulatory requirements and industry standards.

  • Collaborate with cross-functional teams to identify and mitigate risks associated with CAPEX investments.

What we're looking for:

  • Master Degree or equivalent experience in Pharma, Engineering, or Science

  • Proven experience in Pharma / Engineering (GEP/GMP) with an understanding of Fill and Finish Facility Building and processes.

  • Proven experience in Project Management, CQV, governance.

  • People management experience preferred

  • Proficient in English, German is an advantage

  • Understanding of Pharmaceutical/Bio Science "Contract Manufacturing" business and experienced in cGM

  • Strong leadership skills with a global interaction capability.

  • Possess financial and commercial acumen, able to link understanding to project goals, costs & scheduling, and risk.

  • Strong analytical skills for in-depth analysis of complex /large datasets, drawing conclusions and supporting decisions.

Why Lonza ?

Every day, Lonza’s products and services have a positive impact on millions of people. For us, this is not only a great privilege, but also a great responsibility. How we achieve our business results is just as important as the achievements themselves. At Lonza, we respect and protect our people and our environment. Any success we achieve is no success at all if not achieved ethically.

People come to Lonza for the challenge and creativity of solving complex problems and developing new ideas in life sciences. In return, we offer the satisfaction that comes with improving lives all around the world. The satisfaction that comes with making a meaningful difference.

Inclusion is one of Lonza’s four core values, alongside integrity, innovation, and initiative. We understand the value of our differences and the benefits they bring to our company, community, and culture. We also recognize the value of every person’s contribution, regardless of characteristics, preferences, and beliefs – including race, color, ethnicity, sexual orientation, gender identity, and religion.

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Contamination Control and Cleaning, Senior QA Specialist 80-100% (f/m/d)

3930 Visp, Wallis Lonza

Vor 5 Tagen gepostet

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Arbeitsbeschreibung

fulltime, freelancer

Location: Visp, Switzerland. Relocation assistance is available for eligible candidates and their families, if needed.

Today, Lonza is a global leader in life sciences operating across three continents. While we work in science, there’s no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big and small, genuinely improve the world. And that’s the kind of work we want to be part of .

The site in Visp, Switzerland is growing and for our Biologics Quality organization, we are currently looking for a Senior QA Specialist (f/m/d) for Large Scale Mammalian in Ibex® Solutions, our recently launched unique biological manufacturing and development concept. The successful candidate will be part of QA Operations and will be in direct contact with the key stakeholders C ontamination Prevention and Control group, MSAT, Operations, Hygiene etc.

What you’ll get:
  • An agile career and dynamic working culture

  • An inclusive and ethical workplace

  • Compensation programs that recognize high performance

  • A variety of benefits dependant on role and location

What you’ll do:
  • Review and approve the routine cleaning-relevant documents, i.e., routine cleaning plans and reports, MAC plans and cleaning QC plans

  • Ensure all cleaning related deviations are appropriately investigated and recorded, direct the investigations of customer product complaints and assure the completion of the appropriate documentation

  • Be a pa rt of QA Ops working in close contact with contamination Prevention and Control group, MSAT, Ops, Hygiene etc

  • Approve local procedures and ensure that they are compliant with the site Contamination Control Strategy

  • Provide Quality oversight for all CCS topics limited to the facility (local CRs, DRs, and DMS documents)

  • Responsible for review and final release of records like Standard Operating Procedures (SOPs), Master Manufacturing Batch Records, Material Specifications, Deviations, Change Requests, Effectiveness Checks, Testing Protocols & Reports etc.

What we’re looking for :

  • Bachelor / Master degree in Microbiology / C hemistry / Biotechnology or any related field

  • Significant experience i n contamination control in GMP regulated pharmaceutical industry; in a QA role in a Large Scale stainless steel facility is required

  • General knowledge of manufacturing processes , cleaning procedures and analytical methods

  • Experience with GMP management systems like TrackWise , SAP, Syncade and Microsoft suite of products is preferred

  • Experience in the interaction with Health Authorities ( Swissmedic , FDA etc.) is desired

  • Business fluent English is required, able to communicate in or willing to learn German

Every day, Lonza’s products and services have a positive impact on millions of people. For us, this is not only a great privilege, but also a great responsibility. How we achieve our business results is just as important as the achievements themselves. At Lonza, we respect and protect our people and our environment. Any success we achieve is no success at all if not achieved ethically.

People come to Lonza for the challenge and creativity of solving complex problems and developing new ideas in life sciences. In return, we offer the satisfaction that comes with improving lives all around the world. The satisfaction that comes with making a meaningful difference.

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