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

About the role

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.

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.

Requirements

• 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.

Qualifications

• 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.

Pay

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.

Benefits

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