Commissioning, Qualification, and Validation Lead (Pharmaceutical - Construction)

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!

Essential Duties & Responsibilities:

• Lead owner-side CQV governance.
• Develop and maintain the CQV strategy, Validation Master Plan, system boundaries, system classifications, and turnover sequence.
• Integrate qualification and validation requirements into design, procurement, construction, automation, and equipment packages.
• Apply risk-based CQV to facilities, utilities, process systems, manufacturing equipment, laboratories, and automation systems.
• Review user requirements, functional specifications, design specifications, criticality assessments, and traceability documentation.
• Oversee DQ, FAT, SAT, commissioning, IQ, OQ, and PQ activities.
• Define mechanical-completion, pre-commissioning, turnover, commissioning, and qualification requirements.
• Manage system and subsystem turnover from construction through qualification.
• Review turnover packages, vendor documentation, calibration records, testing records, punch lists, protocols, and closeout documentation.
• Manage CQV deviations, discrepancies, incomplete documentation, and corrective actions.
• Coordinate CQV execution with Engineering, Construction, Quality, Manufacturing, Automation, Technical Services, and Operations.
• Track CQV schedule performance and startup constraints.
• Support inspection readiness and facility startup.

Knowledge & Skills Required:

• CQV for cGMP pharmaceutical manufacturing facilities.
• Process equipment, clean utilities, process utilities, HVAC, cleanrooms, laboratories, and automation systems.
• FDA and EMA expectations, ASTM E2500, ISPE guidance, GAMP 5, and risk-based validation.
• FAT, SAT, commissioning, IQ, OQ, and PQ documentation.
• Mechanical completion, system turnover, commissioning, qualification, and startup sequencing.
• Computer System Validation, data integrity, and 21 CFR Part 11.

Preferred Education and Experience:

• Bachelor’s degree in Engineering, Science, Pharmaceutical Technology, or a related discipline.
• 10+ years of pharmaceutical CQV or validation experience.
• 5+ years in a CQV Lead, Validation Manager, or Commissioning Manager role.
• Greenfield API, biologics, peptide, bioconjugate, or cGMP manufacturing experience.
• Experience leading CQV through commercial startup preferred.

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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 $115,700.00-$161,966.69 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:

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