Senior CQV Program Lead – GMP Commissioning Expert

BioSpace; Richmond (VA); On-site; USD 164,000 - 240,000; Full time

Benefits offered by this job

401(k) plan

Pension

Vacation benefits

Health, dental, and vision insurance

Flexible benefits

Job summary

Lilly is seeking a Senior Program C&Q Lead to own commissioning and qualification for a capital program, setting the C&Q strategy, driving field execution, and delivering validated, GMP-compliant systems ready for startup and handover to Site Operations.

The role requires senior technical ownership, coordinating with construction, automation, and QA teams, and ensuring right-first-time execution with audit-ready documentation.

Qualifications

• Bachelor's in Engineering, Life Sciences, or related field.
• 15+ years of commissioning, qualification, and validation (CQV) experience in GMP environments.
• Experience leading CQV execution on capital projects.
• Experience planning and executing FAT with equipment vendors.

Responsibilities

• Define and implement the C&Q strategy, plans, and schedules for the assigned program.
• Coordinate pre-commissioning activities including utility priming, calibration, and equipment installation.
• Plan and lead FAT for the program and witness FAT at vendor sites.
• Author and approve commissioning and qualification protocols and reports.
• Ensure audit-ready records and successful handover to operations.

Skills

CQV leadership

GMP compliance

Project management

Vendor coordination

Field execution

Education

Bachelor's in Engineering, Life Sciences, or related field

Master's degree in engineering, science, or related field

Tools

Kneat

Oracle Unifier

Smartsheet

Power BI

Job description

Lilly is seeking a Senior Program C&Q Lead to own commissioning and qualification for a capital program, setting the C&Q strategy, driving field execution, and delivering validated, GMP-compliant systems ready for startup and handover to Site Operations.

The role requires senior technical ownership, coordinating with construction, automation, and QA teams, and ensuring right-first-time execution with audit-ready documentation.