• Contract
  • Valais
  • Recruiter: Anil Dahiya

Summary

The CQV Engineer Clean Utilities is primarily responsible for the preparation and the execution of the CQV activities relating to Clean Utilities.

Accountabilities

  • Includes, but not limited to, execution of the following activities for the relevant systems in accordance with Project procedures/guidelines:
    • System Boundary development + approval.
    • Design Qualification preparation, execution and approval. Includes release for IQ.
    • GMP-RA’s.
    • Commissioning preparation, execution and approval. Includes vendor supervision on their testing scope and quality.
    • Installation Qualification preparation, execution and approval. Includes release for OQ.
    • Operational Qualification preparation, execution and approval. Includes release to OPS.
  • Provide support in execution of Design Qualification for other direct impact systems.
  • Provide support in the implementation of the Installation Commissioning process in accordance with Project procedures/guidelines.
  • Shall be able to work / support another C&Q activity if deemed necessary.
  • Carry out shift work, where required.
  • Available for travel to vendors / contractors, were required

Candidate profile:

  • Minimum requirements:
  • Minimum Bachelor’s degree in Life Sciences or Engineering
  • Minimum of 2+ years of experience in commissioning / qualification / validation (DQ, IQ, OQ, Commissioning) activities in the pharmaceutical/biotech industry.
  • Proven Clean Utilities knowledge
  • Minimum 2+ years of experience in commissioning / qualification / validation of Clean Utilities Systems.
  • Experience with DeltaV (Emerson).
  • Fluent English language written and verbal communication skills.
  • cGMP knowledge and knowledge of regulatory requirements.
  • Able to work with minimum oversight fulfilling deliverables within target dates.
  • Preferred requirements:
    • Fluent German is a distinct preference.
    • Experience with Commissioning / Qualification Approach.
    • Experience with COMOS/KNEAT platforms.
  • Biopharmaceutical knowledge.