Senior C&Q Program Lead - GMP Capital Projects

Eli Lilly and Company; Houston (TX); On-site; USD 164,000 - 240,000; Full time

Benefits offered by this job

401(k)

Pension

Vacation benefits

Medical, dental, vision benefits

Flexible benefits

Job summary

Lilly seeks a Senior Program C&Q Lead to own commissioning and qualification for a capital program. You will set C&Q strategy, drive field execution with contract teams, and ensure GMP-compliant handover to Site Operations.

Responsibilities include FAT planning, testing strategy, and audit-ready documentation, with global coordination across platforms while maintaining a strong safety culture. Expect travel and leadership of CQV efforts.

Qualifications

• Bachelor's in Engineering, Life Sciences, or related field.
• 15+ years of commissioning, qualification, and validation (CQV) experience in GMP-regulated environments.
• Hands-on experience across the validation lifecycle – commissioning, qualification, startup, and handover.
• Experience planning and executing Factory Acceptance Testing (FAT).
• Ability to travel, within and outside the US, ~35%.
• Authorized to work in the United States on a full-time basis.

Responsibilities

• Create, own, and implement the C&Q strategy, plans, and schedules.
• Direct day-to-day C&Q execution in the field through firms and node leads.
• Review and accept MC turnover and drive closeout of punch list items.
• Coordinate pre-commissioning activities including instrument calibration and automation downloads.
• Plan FAT and coordinate with vendors, engineering, and construction.
• Lead or support handover to Operations and training support.

Skills

CQV experience

Project leadership

Travel up to 35%

Regulatory compliance

Education

Bachelor's degree in Engineering or Life Sciences

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 C&Q strategy, drive field execution with contract teams, and ensure GMP-compliant handover to Site Operations.

Responsibilities include FAT planning, testing strategy, and audit-ready documentation, with global coordination across platforms while maintaining a strong safety culture. Expect travel and leadership of CQV efforts.