The CQV Engineer is responsible for preparing documentation in compliance with cGMP and internal standards for their project, as well as executing CQV activities related to their project area and equipment.
Responsibilities
- Execute key activities for relevant systems according to project procedures and guidelines, including:
- Developing and approving system boundaries.
- Preparing, executing, and approving Design Qualifications, including release for IQ.
- Conducting GMP Risk Assessments.
- Preparing, executing, and approving commissioning activities, including vendor supervision.
- Preparing, executing, and approving Installation Qualifications, including release for OQ.
- Preparing, executing, and approving Operational Qualifications, including release to OPS.
- Support Design Qualification execution for other direct-impact systems.
- Support the Installation Commissioning process per project guidelines.
- Assist with other C&Q activities as needed.
- Participate in shift work as required.
- Be proactive in problem-solving.
- Demonstrate knowledge in Interface Management.
Candidate Profile
Minimum Requirements
- Bachelor’s degree in Life Sciences or Engineering.
- At least 3+ years of experience in commissioning and qualification.
- Experience with DeltaV (Emerson) and other control systems.
- Experience with COMOS/KNEAT platforms.
- Fluent in English, with strong written and verbal communication skills.
- Knowledge of cGMP and regulatory requirements.
- Able to work independently and meet deadlines.
Preferred Requirements
- Experience with recognized industry commissioning/qualification methodologies.
- CQV Execution Engineer experience.
- Biopharmaceutical knowledge and experience.