Commissioning & Qualification (C&Q) Lead

Scorpion Therapeutics; Huntsville (AL); On-site; USD 140,000 - 190,000; Full time

Job summary

Lilly is seeking a senior C&Q leader to own and execute commissioning & qualification strategies for capital projects in GMP environments, including API/LAPI and biologics interfaces. The role requires 15+ years of CQV experience, FAT planning, and field leadership across global teams.

Responsibilities include defining scope, developing schedules, coordinating with construction, automation, and startup milestones, and ensuring audit-ready documentation and regulatory compliance.

Qualifications

• Bachelor’s in Engineering, Life Sciences, or related.
• 15+ years CQV experience in GMP-regulated environments; leading C&Q execution on capital projects.
• Hands-on validation lifecycle experience (commissioning, qualification, turnover, startup support, operations handover).
• Experience planning/executing FAT with equipment vendors.
• Travel ~35% (within/outside US); extended field deployment possible.
• Authorized to work in the US full-time (Lilly does not sponsor visas).
• Directing C&Q contractors/service providers; coordinating with construction teams.
• Influence/results without direct authority in matrixed organizations.
• CQV delivery on greenfield and/or GMP pharmaceutical/life-sciences facilities; mega projects ($100M+).
• CQV experience in API, LAPI, sterile/parenteral, and/or biologics.
• Master’s; ISPE CPIP, PE, or PMP.
• Tools: Kneat, Oracle Unifier, Smartsheet, Power BI.

Responsibilities

• Create, own, and implement the C&Q strategy, plans, and schedules aligned to Lilly CQV standards and manufacturing platform/network requirements (API, LAPI, PDN, LMF).
• Define system boundaries/classification and commissioning/qualification scope and turnover package structure (no gaps/duplication).
• Build and maintain integrated C&Q schedule (critical path, 2–4 week look-aheads, resource loading) and integrate sequencing with construction, automation, and startup milestones.
• Forecast C&Q resource demand and secure right contingent/contract resources.
• Direct day-to-day C&Q execution in the field through C&Q firms and contingent node leads; ensure adherence to procedures and strategy.
• Review/accept mechanical completion (MC) turnover; drive punch list closeout.
• Coordinate pre-commissioning (utility priming, calibration, automation downloads, consumables, VFD setup) and coordinate temporary utilities/power and wastewater/discharge needs.
• Partner on LOTO and transition from construction control to commissioning control.
• Plan/lead FAT (test strategy, protocols, schedules, vendor/engineering coordination); witness FAT, resolve deviations, and confirm release readiness.
• Author/review/approve protocols, test scripts, deviations, and summary reports; ensure audit-ready records.
• Manage structured turnover via PIM (specs, drawings, test records, as-builts, handover packages) to Operations.
• Lead/support system handover (punch resolution, training support, documentation turnover).
• Ensure C&Q meets regulatory/corporate/site quality requirements; support inspection readiness.
• Manage change/deviations with impact assessment and compliance-risk escalation.
• Ensure C&Q activities comply with site safety standards and industry best practices.
• Serve as C&Q SME; coach contract/contingent resources.
• Improve C&Q practices for efficiency while maintaining compliance; feed lessons learned into standards/templates.
• Report progress, risks, and issues to program leadership and Senior Director, Asset Delivery; report C&Q metrics.

Skills

C&Q leadership

Influence without authority

Greenfield projects

GMP pharmaceutical facilities

API/LAPI/biologics CQV

CPIP/PE/PMP certs

Project management

Travel readiness

Education

Bachelor’s degree in Engineering/Life Sciences

Master’s degree (preferred)

CPIP/PE/PMP certifications

Tools

Kneat

Oracle Unifier

Smartsheet

Power BI

Job description

Key Responsibilities

• Create, own, and implement the C&Q strategy, plans, and schedules aligned to Lilly CQV standards and manufacturing platform/network requirements (API, LAPI, PDN, LMF).


• Define system boundaries/classification and commissioning/qualification scope and turnover package structure (no gaps/duplication).


• Build and maintain integrated C&Q schedule (critical path, 2–4 week look-aheads, resource loading) and integrate sequencing with construction, automation, and startup milestones.


• Forecast C&Q resource demand and secure right contingent/contract resources.

C&Q Execution & Field Coordination

• Direct day-to-day C&Q execution in the field through C&Q firms and contingent node leads; ensure adherence to procedures and strategy.


• Review/accept mechanical completion (MC) turnover; drive punch list closeout.


• Coordinate pre-commissioning (utility priming, calibration, automation downloads, consumables, VFD setup) and coordinate temporary utilities/power and wastewater/discharge needs.


• Partner on LOTO and transition from construction control to commissioning control.

Factory Acceptance Testing (FAT)

• Plan/lead FAT (test strategy, protocols, schedules, vendor/engineering coordination); witness FAT, resolve deviations, and confirm release readiness.

Qualification, Documentation & Handover

• Author/review/approve protocols, test scripts, deviations, and summary reports; ensure audit-ready records.


• Manage structured turnover via PIM (specs, drawings, test records, as-builts, handover packages) to Operations.


• Lead/support system handover (punch resolution, training support, documentation turnover).

Quality, Compliance & Safety

• Ensure C&Q meets regulatory/corporate/site quality requirements; support inspection readiness.


• Manage change/deviations with impact assessment and compliance-risk escalation.


• Ensure C&Q activities comply with site safety standards and industry best practices.

Technical Expertise & Continuous Improvement

• Serve as C&Q SME; coach contract/contingent resources.


• Improve C&Q practices for efficiency while maintaining compliance; feed lessons learned into standards/templates.

Reporting & Governance

• Report progress, risks, and issues to program leadership and Senior Director, Asset Delivery; report C&Q metrics.

Qualifications Required

• Bachelor’s in Engineering, Life Sciences, or related.


• 15+ years CQV experience in GMP-regulated environments; leading C&Q execution on capital projects.


• Hands-on validation lifecycle experience (commissioning, qualification, turnover, startup support, operations handover).


• Experience planning/executing FAT with equipment vendors.


• Travel ~35% (within/outside US); extended field deployment possible.


• Authorized to work in the US full-time (Lilly does not sponsor visas).

Preferred

• Directing C&Q contractors/service providers; coordinating with construction teams.


• Influence/results without direct authority in matrixed organizations.


• C&Q delivery on greenfield and/or GMP pharmaceutical/life-sciences facilities; mega projects ($100M+).


• CQV experience in API, LAPI, sterile/parenteral, and/or biologics.


• Master’s; ISPE CPIP, PE, or PMP.


• Tools: Kneat, Oracle Unifier, Smartsheet, Power BI.