Job Opportunities in Switzerland


September 26, 2024

Callista

Stein

OTHER


CQV Technical Lead with Fill Finish Experience

We are seeking a highly skilled Contract CQV (Commissioning, Qualification, and Validation) Technical Lead with extensive Fill Finish experience . The successful candidate will be responsible for leading CQV activities for Fill Finish processes, ensuring compliance with regulatory standards and company procedures.


Key Responsibilities:

  • Lead and execute CQV activities for Fill Finish equipment and processes.
  • Develop and review validation protocols (IQ, OQ, PQ) and reports.
  • Coordinate with cross-functional teams to ensure timely completion of CQV deliverables.
  • Troubleshoot and resolve technical issues related to Fill Finish processes.
  • Ensure adherence to GMP, FDA, and other regulatory requirements.
  • Provide technical expertise and guidance to project teams and stakeholders.
  • Maintain accurate documentation and records of CQV activities.

Qualifications:

  • Bachelor's degree in Engineering, Life Sciences, or related field.
  • Minimum of 5 years of experience in CQV with a focus on Fill Finish processes.
  • Strong knowledge of GMP, FDA, and other regulatory requirements.
  • Excellent problem-solving and analytical skills.
  • Effective communication and team collaboration abilities.
  • Ability to work independently and manage multiple tasks effectively.


Preferred Experience:


  • Experience with aseptic processing and sterile manufacturing.
  • Familiarity with automated systems and equipment used in Fill Finish processes.
  • Project management experience is a plus
  • German speaking

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