What are the responsibilities and job description for the CQV Engineer position at Katalyst Healthcares & Life Sciences?
Roles & Responsibilities:
- Experience in Commissioning, Qualification, and Validation activities for upstream, downstream and support equipment.
- CQV support for all Simple Direct Impact Equipment and No Impact Equipment for all Buildings. Work with equipment and area owners from initial design, procurement, qualification (if required) to final Handover.
- Work with CQV Document Generation Lead in relation to generation and approval of; DQ/Design Reviews/SLIA/Test Matrices/Risk Assessments/QA Vendor Assessments/FAT/SAT/CTP/IOQ Protocols, as required.
- Ensure IV execution is carried out in accordance with engineering specifications, CQV procedures, CQV project strategies, and industry standards such as BPE commissioning and validation guidelines.
- Walking systems to ensure installation is correct (knows how to walk and read P&IDs).
- Support generation of all CQV CIP and SIP Documentation – FAT wraparounds, DQ, RTM, QRA, SAT/IOC, IOQ, PQ including Final Reports.
- Knowledge of GMP (Good Manufacturing Practices) regulations.
- Understanding of FDA (Food and Drug Administration) guidelines.
- Strong analytical and problem-solving skills.
- Excellent communication and teamwork abilities.
- Bachelor's degree in Engineering or related field.
- Certifications in relevant areas (e.g., CQE, CQA) are a plus.
