14 Oct
|
GForce Life Sciences
|
Windsor
14 Oct
GForce Life Sciences
Windsor
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 Role
- Lead 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 CapEx
- Improve 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 experience
- Experience with OEE, downtime reduction, changeover optimization, and run-rate improvement
- Manufacturing scale-up, technology transfer, and facility expansion experience
- Experience developing automation business cases and managing CapEx/equipment implementation
Term & Start
- Immediate need
- In office role in Windsor, Colorado
- Contract-to-hire or direct hire opportunity
📌 Director of Packaging Operations (Windsor)
🏢 GForce Life Sciences
📍 Windsor