Amazing opportunity with one of our Global Bio-Pharmaceutical company in the German speaking part of Switzerland looking for CQV Engineer.
Summary
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 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 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 deliverable within target dates
For further information about this position please apply
*Please note, only those with the right to work in Switzerland can apply!
(Unfortunately we do not sponsor work visa)
