Commissioning & Qualification (C&Q) Lead

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.