Senior C&Q Program Lead - GMP Capital Projects

Eli Lilly and Company; Huntsville (AL); On-site; USD 159,000 - 233,000; Full time

Benefits offered by this job

401(k) matching

Pension

Healthcare (Medical, dental, vision)

Flexible benefits

Life insurance

Job summary

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

You will lead cross‑functional teams, plan FATs, review MC turnover, coordinate with construction, automation, and site utilities, and ensure audit‑ready records while traveling ~35% as required.

Qualifications

• Bachelor's in Engineering, Life Sciences, or a related field.
• 15+ years of CQV experience in GMP environments.
• Experience planning and executing FAT with equipment vendors.

Responsibilities

• Create, own, and implement the C&Q strategy, plans, and schedules for the assigned program.
• Direct day‑to‑day C&Q execution in the field through C&Q firms and contingent leads.
• Plan and lead FAT for the program and coordinate with vendors, engineering, and construction for verification ahead of shipment and startup.
• Lead or support system handover to the User team and Site Operations, including training support and documentation turnover.

Skills

CQV

Commissioning

Validation

Regulatory

Education

Bachelor's in Engineering or Life Sciences

Tools

Kneat

Oracle Unifier

Smartsheet

Power BI

Job description

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

You will lead cross‑functional teams, plan FATs, review MC turnover, coordinate with construction, automation, and site utilities, and ensure audit‑ready records while traveling ~35% as required.