We are currently looking for a Commissioning and Qualification Lead 6 Pharmaceutical / Life Sciences in the Greater Boston, MA area. This role will support complex GMP capital projects, with a focus on C&Q strategy, validation execution, automation systems, and operational readiness.

This is a strong opportunity for someone with deep pharmaceutical C&Q experience who enjoys leading technical workstreams, coordinating contractors, and helping bring highly regulated manufacturing facilities and systems online.

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.

• Coordinate C&Q deliverables across engineering, QA, automation, IT, MS&T, construction, vendors, and site operations.

• Support project schedules, budgets, milestone tracking, change controls, deviations, investigations, and CAPA activities.

• Serve as a C&Q / validation subject matter expert during project reviews, audits, and stakeholder updates.

Technical Requirements:

• Bachelors 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.

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The salary range for this full-time role is $146,400.00-$204,933.36 per year. Ranges are determined based on the position, geography, client and industry experience and level, and represent a good faith effort to provide a fair and equitable salary. This range reflects base salary only, and not the total compensation package. Cumming Group reserves the right to pay more or less than the posted range, depending on a candidates experience, skills, and qualifications, including client requirements.

In addition to base salary, 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