C&Q Lead (Commissioning - Automated Systems)

Cumming Management Group•Devens, MA

1d•Onsite

About The Position

At Cumming Group, you will work on some of the world's most exciting projects in a dynamic environment where your success is measured by the impact you make. We are one of the fastest-growing project and cost management consultancies in the United States, as reflected in our top 10 rankings in ENR. With over 60 offices globally, an extremely diverse project portfolio, and double-digit year-over-year revenue growth, the opportunities to make your mark are limitless! We are currently looking for a Commissioning and Qualification Lead – 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.

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 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.

Nice To Haves

Experience in cell and gene therapy, biologics, advanced therapy manufacturing, or other highly regulated environments preferred.

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.