Pharma CQV Lead: Commissioning, Qualification & Validation

Cumming; Montgomery (AL); On-site; USD 115,700 - 161,967; Full time

Benefits offered by this job

Medical

Dental Insurance

Vision Insurance

401(k)

401(k) Matching

Paid Time Off

Paid Holidays

Short and long-term disability

Employee Assistance Program

Job summary

Cumming Group is seeking a senior professional to lead Commissioning, Qualification and Validation (CQV) activities for pharmaceutical construction projects in the USA, including Alabama and Virginia client sites.

You will develop the CQV strategy, manage DQ/FAT/SAT/IQ/OQ/PQ activities, and coordinate with Engineering, Construction, Quality, and Operations to ensure compliant, on-time startup.

Qualifications

• Lead owner-side CQV governance.
• Develop and maintain CQV strategy, Validation Master Plan, system boundaries and turnover sequence.
• Integrate qualification/validation into design, procurement, construction, automation and equipment packages.
• Apply risk-based CQV to facilities, utilities, process systems, labs and automation.
• Review user requirements, specifications and traceability docs.
• Oversee DQ, FAT, SAT, commissioning, IQ, OQ, PQ activities.
• Define mechanical-completion, pre-commissioning, turnover, commissioning and qualification
• Manage system turnover from construction through qualification.
• Review turnover packages, vendor docs, calibration records & closeout docs.
• Coordinate CQV with Engineering, Construction, Quality, Manufacturing, Automation, Technical Services, Operations.
• Track CQV schedule performance and startup constraints.
• Support inspection readiness and facility startup.

Responsibilities

• Lead owner-side CQV governance and strategy development.
• Ensure CQV activities align with project milestones and regulatory expectations.
• Collaborate across disciplines to integrate CQV into design and construction.

Skills

CQV for pharma facilities

Process equipment & utilities

21 CFR Part 11 & data integrity

DQ/FAT/SAT/IQ/OQ/PQ processes

GMP/regulatory guidance

Project coordination

MS Office

Quality assurance documentation

Education

Bachelor's degree in Engineering, Science, Pharmaceutical Technology, or related

10+ years pharmaceutical CQV/validation experience

Tools

Validation software

QA documentation tools

Job description

Cumming Group is seeking a senior professional to lead Commissioning, Qualification and Validation (CQV) activities for pharmaceutical construction projects in the USA, including Alabama and Virginia client sites.

You will develop the CQV strategy, manage DQ/FAT/SAT/IQ/OQ/PQ activities, and coordinate with Engineering, Construction, Quality, and Operations to ensure compliant, on-time startup.