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Devens, Massachusetts, United States
Onsite
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.
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:
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.
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Cumming Group is committed to providing Equal Employment Opportunity in its personnel policies and practices. It is Cumming Group’s policy to recruit, hire, train and promote Team Members and applicants for employment without regard to race, color, creed, religion, age, sex, marital status, registered domestic partner status, genetic information, sexual preference, sexual orientation, gender (including gender expression and gender identity), pregnancy (including childbirth or related medical conditions, including breastfeeding), military service, national origin, ancestry, citizenship, physical disability, mental disability, veteran status or any other protected classification under federal, state, or local law. All such decisions are based on (1) individual merit, qualifications, and competence as they relate to the particular position, and (2) promotion of the principle of equal employment opportunity.
All other terms and conditions of employment, such as compensation, benefits, transfers, layoff, return from layoff, training, education, and social and recreational programs, are administered without regard to the characteristics described above. To this end, Cumming Group complies with all provisions of Title VII of the Civil Rights Act of 1964 as amended, all of the rules, regulations and relevant orders of the Secretary of Labor, and all similar state and local laws.
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 candidate’s experience, skills, and qualifications, including client requirements.
In addition to base salary, Cumming Group offers a comprehensive benefits package including: