C&Q Lead (Commissioning Automated Systems)

At Cumming Group you will work on some of the worlds 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:

• 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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Cumming Group is committed to providing Equal Employment Opportunity in its personnel policies and practices. It is Cumming Groups 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.

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