Sr Technician Production, Upstream
Incyte Corporation
Yverdon,
vor 5 Tg.

Job Summary (Primary function)

During the construction and facility startup phase, the Production Technologist Manager will be responsible for commissioning and qualification of USP equipment and areas.

This may include medium preparation, inoculum, bioreactors (rockers, STR), depth filtration, and cell clarification equipment.

During manufacturing operation, the Production Technologist Manager will develop in an operation based role such as subject matter expert for area of responsibility and / or shift supervisor.

Essential Functions of the Job (Key responsibilities)

  • During the construction phase, you will mainly :
  • Author, review and maintain comprehensive systems requirements (URS)
  • Actively participate in the definition and review of the Qualification Master Plan
  • Review Vendor Quality & Project Plans and Qualification / Test Plans
  • Actively participate in Regular calls, visits, status updates with process equipment manufacturers
  • Perform FAT, SAT, IQ, Commissioning and OQ. Up to 25% European travel required
  • Own (develop, document, apply, close) Change Controls and deviations including any corrective actions arising during verifications
  • Revise and approve test reports
  • Perform and report PQ activities
  • Prepare and deliver training to new members of the team
  • During the operation phase, you will mainly :

  • Author, review, approve, maintain life cycle ( etc.) of all required Standard Operating Procedures, Work Instructions, Manufacturing Batch Records, PQ protocols and other quality documents related to areas of responsibility, as well as support other areas as required
  • Act as a mentor to more junior team members and lead by example to ensure timely batch execution, and proactively propose problem resolution
  • Raise, investigate and close events, deviations and non-conformances
  • Manage, plan, lead and execute batch related activities
  • Qualifications (Minimal acceptable level of education, work experience, and competency)

  • Biotechnology or pharmaceutical BSc (e.g. Swiss HES) degree preferred or relevant experience from chemical, food, pharmaceutical or biotech industry
  • Must have hands-on experience of equipment commissioning and qualification
  • Demonstrated, solid hands on experience of USP manufacturing typically 4 years
  • Shift work is expected
  • Ability to work in a fast paced high regulated environment
  • French and English (Fluent)
  • Team work oriented mindset
  • Contribute positively to a strong culture of business integrity and ethics
  • Act within compliance and legal requirements as well as within company guidelines
  • Disclaimer : The above statements are intended to describe the general nature and level of work performed by employees assigned to this job.

    They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications. Management reserves the right to change or modify such duties as required.

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