Senior Commissioning and Qualifications Engineer
2 mesi fa
At Cai, we are seeking a skilled Commissioning, Qualification, and Validation (CQV) Engineer to support the Commissioning, Qualification, and Validation of pharmaceutical facilities, utilities, and equipment.
Main Responsibilities:- Develop documentation to support Commissioning, Qualification, and Validation activities
- Responsible for protocol writing and execution, field verification, and development of summary reports at client sites
- Support onsite and offsite activities, such as FATs, SATs, IOQ and PQ Executions and System Walkdowns
Requirements:
- High attention to detail
- Ability to multi-task and take initiative to accomplish assigned tasks accurately
- Minimum 4 – 8 years' experience performing commissioning and / or qualification activities in an FDA regulated industry
- Proficient in life science manufacturing processes in areas such as biotech, aseptic processing, aseptic fill/finish, OSD, Gene Therapy or equivalent experience
Preferred Skills:
- Expertise in Microsoft Word and Excel
- Familiarity with Baseline Guide 5 (Second Edition)
What We Offer:
- Excellent technical problem-solving and troubleshooting skills
- Leadership and guidance for the integration and delivery of CQV services for our Life Sciences clients
About Us:
Cai is a leading provider of CQV services for the Life Sciences industry. We pride ourselves on our commitment to delivering high-quality services and solutions to our clients. We are looking for talented individuals who share our passion for excellence and are dedicated to making a difference in the industry.
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