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