Biopharmaceutical CQV SPECIALIST
$80,000–$100,000 year
On-siteRaleigh, North Carolina, United States
Job Summary
Lead the commissioning, qualification, and start-up of pharmaceutical/biopharmaceutical process equipment, utilities, and facilities, providing technical guidance and developing/leading deliverables such as DQ, FAT, SAT, IQ, OQ, and PQ throughout the project lifecycle. Perform field execution of qualification protocols, support development of Project Validation Plans, and ensure adherence to cGMP and client requirements. Coordinate cross-functional meetings, oversee validation activities, mentor junior staff, and manage multiple projects across client sites with occasional travel. Responsibilities include client-management support, project scheduling/budgeting, and presenting at industry venues; travel to client sites in Raleigh, NC, and other locations as required. Compliance with client safety policies, including vaccination requirements where applicable, is expected.
Required Qualifications
- 3+ years of commissioning, qualification, and validation experience in pharmaceutical/biotech environments
- Experience with commissioning and qualification of process equipment and facilities
- Experience developing and executing validation projects (Risk-Based C&Q approaches) and related deliverables (DQ, FAT, SAT, IQ, OQ, PQ)
- Engineering degree in Mechanical, Electrical, or Chemical fields
- Ability to travel to client sites and work extended hours during installation, commissioning, or validation phases
- Knowledge of regulatory requirements and best practices in pharma/biotech environments
Hiring someone like this?
Get your role in front of qualified candidates on Sorce.