CQV Engineer

vor 4 Wochen

Visp, Schweiz Randstad Vollzeit
For our client, an international company in Visp, we are looking for a CQV Engineer.

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

General Information: Start date: ASAPLatest start date: October 2024Contract duration: 1 yearWorkplace: VispWorkload: 100%Home office: not possible

Responsibilities ((includes but is not limited to):
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-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.
System Responsibilities:

The list of the systems for which the CQV Engineer is responsible, depends on the assigned equipment group and will be shared with the holder of the position at job start. The equipment group for which the candidate will get assigned to, will be evaluated during the interview and will be communicated to the candidate with the job offer. The system scope for which the CQV Engineer will be responsible may evolve over time and may gets updated as the project progresses.

Your Profile:
Minimum Bachelor's degree in Life Sciences or EngineeringMinimum 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.

Nice to have:
Fluent GermanExperience with COMOS/KNEAT platforms

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