CQV Lead

Digital Prospectors; Portsmouth (NH); On-site; USD 110,000 - 165,000; Full time

Job summary

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

The ideal candidate will lead IQ/OQ/PQ for automated aseptic filling equipment, qualify utilities and HVAC systems, and leverage FAT/SAT approaches with baseline methodologies.

Qualifications

• 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.

Responsibilities

• 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

Skills

CQV for aseptic filling

IQ/OQ/PQ execution

Utilities & HVAC knowledge

GMP documentation

Kneat eVLMS

Tools

Kneat eVLMS

Job description

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.

Essential Duties and Responsibilities

• 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

Qualifications

• 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.

Come see why DPC has achieved

• 4.9/5 Star Glassdoor rating and the only staffing company (< 1000 employees) to be voted in the national Top 10 ‘Employee’s Choice - Best Places to Work’ by Glassdoor.
• Voted ‘Best Staffing Firm to Temp/Contract For’ seven times by Staffing Industry Analysts as well as a ‘Best Company to Work For’ by Forbes, Fortune and Inc. magazine.