CQV Lead

Seeking an experienced CQV Lead / CQV Engineer to support the commissioning, qualification, and validation in a manufacturing environment. This role will support startup/shakedown, C&Q execution, and GMP release activities in alignment with the Global Engineering standards.

• Lead and/or execute Commissioning, Qualification (IQ/OQ/PQ), and CSV activities for automated aseptic filling equipment
• Support C&Q strategy development, execution planning, and schedule generation
• Execute utility qualification (compressed air), HVAC/AHU IQ/OQ, and cleanroom environmental PQ
• Perform Syntegon filler IQ/OQ, including automation, PLC/HMI verification, alarms, interlocks, and FAT/SAT leverage
• Execute Performance Qualification (PQ) runs and support GMP release documentation
• Qualify ancillary equipment including vial cleaner (BSC) and filler HVAC systems
• Review vendor qualification documentation; support data review and summary reporting
• Utilize Kneat (eVLMS) for protocol execution and documentation

• Strong background in CQV for aseptic filling systems (viral vectors or biologics preferred)
• Hands‑on experience with IQ/OQ/PQ execution, utilities, HVAC, and classified environments
• Experience qualifying automated filling lines and isolator‑based systems
• Familiarity with FAT/SAT leveraging and Baseline Guide 5 / Group‑based qualification approaches
• Prior experience with Kneat eVLMS highly preferred
• GMP documentation, deviation management, and data review experience

POST-OFFER BACKGROUND CHECK IS REQUIRED. Digital Prospectors is an Equal Opportunity Employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, or any other characteristic protected by law. Digital Prospectors affirms the right of all individuals to equal opportunity and prohibits any form of discrimination or harassment.

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