CQV Engineer (5514)
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CQV Engineer – 5514
Our client, a global market leader in the production and process support of active pharmaceutical ingredients, both in the chemical and biotechnology sectors, is looking for a CQV Engineer to be responsible for the preparation and the execution of the CQV activities.
The position is based in Visp, Switzerland for a 12 months contract with extension.
Main Responsibilities:
- Includes, but not limited to, execution of the following activities for the relevant systems in accordance with Project procedures/guidelines:
o System Boundary development + approval.
o Design Qualification preparation, execution and approval. Includes release for IQ.
o GMP-RA’s.
o Commissioning preparation, execution and approval: includes vendor supervision on their testing scope and quality.
o Installation Qualification preparation, execution and approval: includes release for OQ.
o 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
Qualifications and Experience:
- Relevant working/residency permit or Swiss/EU-Citizenship required.
- 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).
- cGMP knowledge and knowledge of regulatory requirements.
- Able to work with minimum oversight fulfilling deliverables within target dates.
- Fluent English language written and verbal communication skills.
- Fluent German is a distinct preference.
- Ideally experience with COMOS/KNEAT platforms.
- Ideally Biopharmaceutical knowledge.
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