Senior CQV Program Lead: GMP Validation & Start-Up Impact

BioSpace; Huntsville (AL); On-site; USD 159,000 - 233,000; Full time

Benefits offered by this job

401(k)

Pension

Vacation benefits

Medical benefits

Flexible benefits

Life insurance

Time off

Well-being programs

Job summary

Lilly seeks a Senior Program C&Q Lead to own commissioning and qualification for a capital program. You will set the C&Q strategy, drive field execution, and ensure systems are validated, GMP-compliant, and ready for startup and handover to Site Operations.

The role requires 15+ years in CQV, hands-on validation lifecycle expertise, FAT planning, and the ability to travel within the US. Strong leadership in a matrixed environment is essential.

Qualifications

• 15+ years of commissioning, qualification, and validation (CQV) experience in GMP-regulated environments.
• Hands-on experience across the validation lifecycle – commissioning, qualification, systems turnover, startup support, and handover to operations.
• Experience planning and executing Factory Acceptance Testing (FAT) with equipment vendors.

Responsibilities

• Create, own, and implement C&Q strategy, plans, and schedules aligned to CQV standards.
• Direct day-to-day C&Q execution in the field through C&Q firms and contingent leads.
• Coordinate pre-commissioning activities including utility priming and instrument calibration.
• Lead or support system handover to User teams and Site Operations with documentation turnover.
• Report progress, risks, and issues to program leadership and Senior Director.

Skills

CQV experience

Commissioning

Validation

Regulatory compliance

Education

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

Tools

Kneat

Oracle Unifier

Smartsheet

Power BI

Job description

Lilly seeks a Senior Program C&Q Lead to own commissioning and qualification for a capital program. You will set the C&Q strategy, drive field execution, and ensure systems are validated, GMP-compliant, and ready for startup and handover to Site Operations.

The role requires 15+ years in CQV, hands-on validation lifecycle expertise, FAT planning, and the ability to travel within the US. Strong leadership in a matrixed environment is essential.