Associate Director - Device, Assembly, and Packaging
Eli Lilly and Company
August 24, 2026
On-site
Pleasant Prairie, WI
Operations
Responsibilities:
- During project phase: staff, train, and lead operations group supporting asset delivery, process development, operations readiness, start up, and validation of parenteral operations (PAR) and/or device, assembly, and packaging (DAP).
- After facility turnover: ensure annual production goals and planning through 1–3-year horizons.
- Lead cross-functional process teams. Direct supervision includes Supervisors and Operations Associates.
Key Objectives/Deliverables:
- Encourage and exercise “Stop Work Authority” for unsafe or product-impacting situations.
- Lead area deviation and corrective action discussions with Engineering, Maintenance, TS/MS, Quality, and HSE.
- Present operations investigations/procedures to regulatory agencies; serve as SME for inspections/tours.
- Ensure shift-to-shift consistency via shop-floor engagement, Gemba walks, and Practice vs. Procedure evaluations.
- Maintain/communicate performance metrics and drive continuous improvement.
- Support strategies for Continuous Improvement, RCA, FMEA, and OSSCE.
- Understand/influence manufacturing control strategy.
- Support site leadership; deliver operational procedures, quality processes and controls for Parenteral/DAP.
- Lead ~40–70 individuals across shifts.
- Provide leadership and set objectives to deliver Business Plan goals (production volumes, finances, safety, quality, stewardship, people).
- Primary contact for Production Planning, HR, Quality Assurance, Engineering, and Environmental/Safety.
- Lead Operations Process Team and represent it on the Plant Flow (value stream) Team.
Basic Qualifications:
- Bachelor’s degree in STEM or pharmaceutical field.
- 7+ years in pharmaceutical industry.
- Prior management/leadership experience with cross-functional teams.
- Solid understanding of regulatory requirements (FDA, EMEA, DEKRA, and/or OSHA).
- Strong interpersonal, written, oral, and electronic communication.
- Technical aptitude; ability to train and mentor.
Additional Skills/Preferences:
- 6+ years manufacturing/operations; 4+ years supervisory.
- cGMP and FDA (or other) production guidelines.
- Experience with highly automated equipment; create SOPs/work instructions/training docs.
- Equipment/facility design reviews; start-up; qualification/validation.
- Manufacturing execution systems and electronic batch release.
- ASRS or AGVs; lean/six sigma; documentation/deviation/change management systems (e.g., Trackwise, Veeva, QualityDocs, Kneat).
Additional Information:
- Ability to wear safety equipment.
- Work 8 hours/day, Monday–Friday, with overtime as required.
- During project phase: staff, train, and lead operations group supporting asset delivery, process development, operations readiness, start up, and validation of parenteral operations (PAR) and/or device, assembly, and packaging (DAP).
- After facility turnover: ensure annual production goals and planning through 1–3-year horizons.
- Lead cross-functional process teams. Direct supervision includes Supervisors and Operations Associates.
Key Objectives/Deliverables:
- Encourage and exercise “Stop Work Authority” for unsafe or product-impacting situations.
- Lead area deviation and corrective action discussions with Engineering, Maintenance, TS/MS, Quality, and HSE.
- Present operations investigations/procedures to regulatory agencies; serve as SME for inspections/tours.
- Ensure shift-to-shift consistency via shop-floor engagement, Gemba walks, and Practice vs. Procedure evaluations.
- Maintain/communicate performance metrics and drive continuous improvement.
- Support strategies for Continuous Improvement, RCA, FMEA, and OSSCE.
- Understand/influence manufacturing control strategy.
- Support site leadership; deliver operational procedures, quality processes and controls for Parenteral/DAP.
- Lead ~40–70 individuals across shifts.
- Provide leadership and set objectives to deliver Business Plan goals (production volumes, finances, safety, quality, stewardship, people).
- Primary contact for Production Planning, HR, Quality Assurance, Engineering, and Environmental/Safety.
- Lead Operations Process Team and represent it on the Plant Flow (value stream) Team.
Basic Qualifications:
- Bachelor’s degree in STEM or pharmaceutical field.
- 7+ years in pharmaceutical industry.
- Prior management/leadership experience with cross-functional teams.
- Solid understanding of regulatory requirements (FDA, EMEA, DEKRA, and/or OSHA).
- Strong interpersonal, written, oral, and electronic communication.
- Technical aptitude; ability to train and mentor.
Additional Skills/Preferences:
- 6+ years manufacturing/operations; 4+ years supervisory.
- cGMP and FDA (or other) production guidelines.
- Experience with highly automated equipment; create SOPs/work instructions/training docs.
- Equipment/facility design reviews; start-up; qualification/validation.
- Manufacturing execution systems and electronic batch release.
- ASRS or AGVs; lean/six sigma; documentation/deviation/change management systems (e.g., Trackwise, Veeva, QualityDocs, Kneat).
Additional Information:
- Ability to wear safety equipment.
- Work 8 hours/day, Monday–Friday, with overtime as required.