Senior C&Q Program Lead: GMP Validation & Startup Ready

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

Benefits offered by this job

401(k) plan

Pension

Health benefits

Vacation benefits

Well-being programs

Job summary

Lilly is seeking a Senior Program C&Q Lead to own commissioning and qualification strategy for assigned capital programs. You will drive field execution, coordinate with construction and automation teams, and ensure GMP-compliant systems ready for startup and handover.

The role requires 15+ years in CQV, ability to travel, and a track record delivering FAT and CQV on major projects. Mastery of CQV platforms and strong cross-functional collaboration are essential.

Qualifications

• Bachelor’s in Engineering, Life Sciences or related field.
• 15+ years CQV/validation experience in GMP environments.
• Experience leading CQV on capital projects.
• Willingness to travel ~35% domestically and internationally.
• Authorized to work in the United States (full-time).

Responsibilities

• Define C&Q strategy, plans, and schedules for the program.
• Direct day-to-day C&Q execution in the field with contractors.
• Lead FAT planning, execution, and vendor coordination.
• Author and review commissioning/qualification protocols and reports.
• Ensure audit-ready records and handover to operations.

Skills

CQV expertise

Project leadership

Regulatory compliance

Industrial automation

Education

Bachelor’s in Engineering

Bachelor’s in Life Sciences

Master’s degree (engineering/science)

Tools

Kneat

Oracle Unifier

Smartsheet

Power BI

Job description

Lilly is seeking a Senior Program C&Q Lead to own commissioning and qualification strategy for assigned capital programs. You will drive field execution, coordinate with construction and automation teams, and ensure GMP-compliant systems ready for startup and handover.

The role requires 15+ years in CQV, ability to travel, and a track record delivering FAT and CQV on major projects. Mastery of CQV platforms and strong cross-functional collaboration are essential.