CQV Engineer (m/f/d)

Background:

The CQ Engineer is primarily responsible for the preparation of documentation in compliance with cGMP and all internal standards pertaining to their specific project and the execution of the CQV activities corresponding to their project’s area and equipment

Your Responsibilities:

• 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 for execution of documentation related to URS, FAT/SAT procedures
• Provide support in the implementation of the Installation Commissioning process in accordance with Project procedures/guidelines.
• Knowledge of NH3 and other Gases associated with large Freezers and Chillers.
• Knowledge of PSSR write ups and system checks
• Knowledge of HVAC and Utility systems
• Shall be able to work / support another C&Q activity if deemed necessary.
• Carry out shift work, where required.

Your Profile:

• Bachelor’s degree in Life Sciences or Engineering
• At least 3+ years of experience in commissioning / qualification / validation (DQ, IQ, OQ, Commissioning) activities in the pharmaceutical/biotech industry.
• Proven Utilities/Upstream knowledge
• At least 3+ years of experience in commissioning / qualification / validation of biopharmaceutical related systems and utilities.
• Experience with DeltaV (Emerson) and other Control Systems
• 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 Haves:

• Fluent German
• Experience with COMOS/KNEAT platform
• Biopharmaceutical Knowledge