Summary:
Our client is seeking an experienced manufacturing leader to oversee a complex pharmaceutical packaging operation supporting highly automated syringe assembly, labeling, visual inspection, packaging, equipment reliability, regulatory readiness, and process improvement. This individual will provide strategic and operational leadership across a multi-shift packaging organization while improving equipment performance, throughput, changeovers, and team capability. Duties / Expectations of RoleLead packaging, visual inspection, labeling, and related operations across a multi-shift pharmaceutical manufacturing environment Directly oversee managers, supervisors, and an approximately 40–50 person packaging organization across three shifts Improve performance of highly automated packaging assets, including customized syringe-connecting robotics, the Syringe Assembly Machine (SAM), labeling equipment, and the carton case packer/palletizer (CCP) Drive OEE, run-rate, downtime, changeover, scrap, and schedule-attainment improvements across packaging operations Partner closely with Engineering to diagnose technical gaps, resolve recurring equipment failures, and restore equipment to expected performance Lead complex investigations, deviation reduction, root cause analysis, CAPAs, and GMP compliance activities related to packaging and equipment performance Optimize packaging operations for high-mix, low-volume production, including frequent changeovers and equipment ramp-up constraints Evaluate and develop business cases for automation, including automated visual inspection and additional future CapExImprove manual visual inspection processes for Paloperidone and support automation opportunities while maintaining product quality and compliance Partner with Quality, MS&T, Manufacturing, Engineering, and other functions to ensure new equipment is fit-for-purpose and user-friendly Support FDA inspection readiness, mock-audit remediation, and ongoing regulatory compliance Develop managers and supervisors through coaching, accountability, performance management, and floor-level engagement
Mandatory Requirements:- Bachelor's degree in Engineering, Life Sciences, Manufacturing, or related technical discipline 10+ years of pharmaceutical, medical device, or highly regulated manufacturing experience
- Strong experience leading automated manufacturing, packaging, assembly, or related production operations
- Experience leading managers, supervisors, and multi-shift manufacturing organizations
- Strong technical background in automated equipment, process troubleshooting, and manufacturing systems
- Experience managing investigations, deviations, CAPAs, root cause analysis, and GMP/compliance activities
- Experience supporting FDA inspections, regulatory audits, and inspection readiness
- Proven success improving equipment reliability, throughput, OEE, and manufacturing efficiency
- Excellent people leadership, communication, and cross-functional collaboration skills
- Ability to work fully on-site within a multi-shift manufacturing operation
Nice to Have:- Director or Senior Director-level manufacturing leadership experience
- Pharmaceutical packaging, sterile injectable packaging, combination product, syringe, or automated assembly experience
- Engineering background with advanced equipment troubleshooting and automation expertise
- High-mix, low-volume manufacturing experience
- Lean Manufacturing, Six Sigma, SMED, Continuous Improvement, or Operational Excellence experienceExperience with OEE, downtime reduction, changeover optimization, and run-rate improvement
- Manufacturing scale-up, technology transfer, and facility expansion experienceExperience developing automation business cases and managing CapEx/equipment implementation
- Term & Start
- Immediate need
- On-site role in Windsor, Colorado
- Contract-to-hire or direct hire opportunity
- Benefits included
