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CQV Engineer (f/m/d).

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job details

summary.

  • specialism
    construction
  • contact
    Nikolina Babic
  • reference number
    215912-57

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job details

For Lonza SGIE AG in Visp we are looking for CQV Engineer.

The CQV Engineer is primarily responsible for the preparation and the execution of the CQV activities as per below responsibilities.

Responsibilities:

  • Execution of the following activities for the relevant systems in accordance with Vibe-X Project procedures/guidelines:
    • System Boundary development & approval.
    • Design Qualification preparation, execution and approval. Includes release for IQ GMP-RAs.
    • 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.

For Lonza SGIE AG in Visp we are looking for CQV Engineer.

The CQV Engineer is primarily responsible for the preparation and the execution of the CQV activities as per below responsibilities.

Responsibilities:

  • Execution of the following activities for the relevant systems in accordance with Vibe-X Project procedures/guidelines:
    • System Boundary development & approval.
    • Design Qualification preparation, execution and approval. Includes release for IQ GMP-RAs.
    • 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.

  • qualifications

    • 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 Process or Utility Equipment experience (either DSP, USP, Bioconjugates or Clean Utilities)

    • 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.

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Nikolina Babic

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