Summary

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

Accountabilities

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.
- 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 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.