Sr. Technician Production, Downstream
Incyte Corporation
vor 1 Tg.

Job Summary (Primary function)

During the construction and facility startup phase, the Downstream Production Technician will be responsible for executing commissioning and qualification protocols of DSP equipment and areas.

This may include product and solution mixers, chromatography skid and packing, viral inactivation, normal filtration, viral Filtration, UFDF, etc.

During manufacturing operation, the Downstream Production Technician will develop in an operations based role.

Essential Functions of the Job (Key responsibilities)

During the construction phase, you will mainly :

  • Draft, 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
  • Support Change Controls and deviations including any corrective actions arising during verifications
  • Execute and review test reports
  • Perform and report PQ activities
  • Prepare and deliver training to new members of the team
  • During operational phase, you will mainly :

  • Draft, review 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 an example in the cleanroom to ensure timely batch execution, and proactively propose problem resolution
  • Raise, investigate and close events, deviations and non-conformances
  • Execute batch related activities
  • Actively participate in continuous improvement initiatives - proposing and implementing with team
  • Qualifications (Minimal acceptable level of education, work experience, and competency)

  • Biotechnology or pharmaceutical degree preferred or relevant experience from chemical, food, pharmaceutical or biotech industry
  • Demonstrated, hands on experience of DSP manufacturing
  • Shift work is expected
  • Ability to work in a fast paced high regulated environment
  • French and English
  • 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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