CQV Lead (cGMP - Pharmaceutical)

Responsibilities

• Lead commissioning, qualification, and validation activities for GMP capital projects.
• Develop, review, and approve C&Q plans, validation plans, protocols, reports, and related technical documentation.
• Oversee C&Q contractors and technical workstreams supporting facilities, utilities, process equipment, automation, and computerized systems.
• Drive risk-based qualification strategies, including acceptance criteria, testing requirements, documentation approach, and regulatory alignment.
• Capture C&Q deliverables across engineering, QA, automation, IT, MS&T, construction, vendors, and site operations.
• Serve as a C&Q / validation subject matter expert during project reviews, audits, and stakeholder updates.

Requirements

• Bachelor’s degree in Engineering, Life Sciences, Computer Science, or a related technical discipline required.
• 10+ years of pharmaceutical, biotechnology, life sciences, or GMP manufacturing experience.
• Strong background in commissioning, qualification, validation, and GMP project execution.
• Experience in cell and gene therapy, biologics, advanced therapy manufacturing, or other highly regulated environments preferred.
• Experience supporting large capital projects involving GMP facilities, utilities, process equipment, automation, and/or computerized systems.
• Knowledge of PLCs, SCADA, DCS, MES, CSV, data integrity, 21 CFR Part 11, and GAMP 5.
• Familiarity with ASTM E2500, FDA, EMA, ICH, Annex 11, and Annex 15 requirements.

Technical Requirements

• Bachelor’s degree in Engineering, Life Sciences, Computer Science, or a related technical discipline required.
• 10+ years of pharmaceutical, biotechnology, life sciences, or GMP manufacturing experience.
• Strong background in commissioning, qualification, validation, and GMP project execution.
• Experience in cell and gene therapy, biologics, advanced therapy manufacturing, or other highly regulated environments preferred.
• Experience supporting large capital projects involving GMP facilities, utilities, process equipment, automation, and/or computerized systems.
• Knowledge of PLCs, SCADA, DCS, MES, CSV, data integrity, 21 CFR Part 11, and GAMP 5.
• Familiarity with ASTM E2500, FDA, EMA, ICH, Annex 11, and Annex 15 requirements.

Benefits

Cumming Group offers a comprehensive benefits package including:

• Medical
• Dental Insurance
• Vision Insurance
• 401(k)
• 401(k) Matching
• Paid Time Off
• Paid Holidays
• Short and long-term disability
• Employee Assistance Program

Pay

The salary range for this full-time role is $146,400.00-$204,933.36 per year.

Schedule

This is a full-time role.