Engineer, Manufacturing
Jobbeschreibung
Couvet, Neuenburg, Schweiz
WuXi AppTec
03.05.2024
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OverviewThe Engineer, Manufacturing is involved in the new product
introduction of oral solid dosage forms (capsules and tablets) in the
site of Couvet. He/she is involved in all the technical activities
related to manufacturing. He/she authors, owns and leads updates of
GMP documents related to new product introduction for Bulk and/or
Packaging Operations. He/she trains the operational teams to the
protocol/master batch record for the new product.ResponsibilitiesThe
Manufacturing Engineer's main activities are completed autonomously
for the following tasks and responsibilities: Author and review
manufacturing (bulk/packaging) documents, including specifications,
working practices, transfer protocol, master batch record, Forms and
logbooks. Follow up approval flow within electronic documentations
system and facilitate all stakeholders input to ensure documents are
updated and approved in a timely manner.Is the key contact for
manufacturing topics related to new product introduction (collect the
input from operational team, provide feedback/input to the NPI
manager).Act as a SME for manufacturing topics with customer for the
assigned project.Develop the technical transfer plan and issue the
documentation related to the manufacture/packaging of new products in
collaboration with bulk, packaging, NPI and quality departments.Follow
the manufacturing and packaging activities related to new product
introduction on-the-floor with the production team.Train the
operational team (operator, technician) to the protocol/master batch
record as required.Initiate deviations and participate to or lead on
the floor investigations. Partner with QA and Packaging or Bulk
Operations to ensure assessments and investigations are
exhaustive.Lead risk assessments within cross functional teams (from
draft to approval).Support Critical Quality Attributes and Critical
Process Parameters definition and implementation.Contribute to
continuous improvement, including proactively identifying problems,
gathering input from the operational team and proposing
solutions.QualificationsExperience / EducationBS/MS in
Engineering/Technical discipline or equivalent experience3 years'
experience in pharmaceutical validation, packaging or related
fieldKnowledge / Skills / Abilities:Sound knowledge of current
international regulatory regulations, cGxP requirements and best
practices, including 21 CFR part 11, 210 and 211, Annex 11, EU-GMP
guidelines and CAMPExperienced in Health Authority inspections
(preparation, process, presentations, responses drafting,
etc).Knowledge of pharmaceutical facilities, manufacturing, and
laboratory systems and processes.Well-developed ability to
constructively work across functional areas and levels to achieve
results,Strong verbal and written communication skills,Strong
analytical, problem solving, influential and deductive
skills,Capability to work with short deadlines and simultaneous
activities,Excellent organizational and project management
skills,Fluent in English and in French.An Equal Opportunity Employer.
All qualified applicants will receive consideration for employment
without regard to race, color, religion, sex, sexual orientation,
gender identity, national origin, or protected veteran status and will
not be discriminated against on the basis of disabilityThis job
description does not state or imply that the above are the only duties
and responsibilities assigned to this position. Employees holding this
position will be required to perform any other job-related duties as
requested by Management.Job SummaryJob ID: 2024-12553