Pharmaceutical Commissioning and Validation Specialist
4 days ago
Job Summary:
- We are seeking a highly skilled Pharmaceutical Commissioning and Validation Specialist to join our operations.
About the Role:
- This is an exceptional opportunity for an experienced professional to develop and execute commissioning and qualification plans for pharmaceutical facilities, utilities, and equipment.
- The successful candidate will be responsible for creating documentation to support commissioning, qualification, and validation activities, as well as providing technical leadership and guidance to ensure high-quality delivery of CQV services.
Responsibilities:
- Develop and execute comprehensive commissioning and qualification plans, including protocol writing and execution (field verification), and development of summary reports at client sites.
- Provide technical expertise and guidance on cGMP compliance, commissioning, and qualification best practices to ensure seamless integration and delivery of CQV services.
- Manage the entire lifecycle of C&Q documentation and execution from SLIA generation through to OQ completion, ensuring accurate and timely delivery of high-quality documents.
Requirements:
- Bachelor's or Master's degree in a relevant science or engineering field, or equivalent years of hands-on experience.
- At least 5-12 years' experience performing commissioning and/or qualification activities in an FDA-regulated industry, with a strong focus on pharmaceutical manufacturing processes and equipment.
- Demonstrated expertise in facilities and equipment startup, walk-downs & troubleshooting, utilities (WFI, RO, HVAC), building automation, and other pharmaceutical manufacturing processes and equipment.
- Excellent technical problem-solving and troubleshooting skills, with solid knowledge of typical project technical issues.
- High attention to detail and ability to multitask, taking initiative to accomplish assigned tasks accurately by established deadlines.
Key Skills:
- Commissioning and Qualification
- Cycle Development and Operations
- Document Control and Management
- Culture and Facilities
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