Production Technologist Manager Downstream

Location
Switzerland
Salary
On Application
Posted
19 Nov 2018
Closes
19 Dec 2018
Ref
CWi
Discipline
Quality, QA / QC
Contract Type
Contract

Job Summary (Primary function)

  • During the construction and facility startup phase, the Production Technologist Manager will be responsible for commissioning and qualification of DSP equipment and areas.
  • This may include product and solution mixers, chromatography skid and packing, viral inactivation, normal filtration, viral Filtration, UFDF ….
  • 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 (eg. 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 DSP manufacturing – typically 5-10 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

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