Director of Packaging Operations

Institute of Packaging Professionals; Windsor (CO); On-site; USD 150,000 - 210,000; Full time

Benefits offered by this job

Benefits included

Job summary

Institute of Packaging Professionals seeks an experienced manufacturing leader to oversee a complex pharmaceutical packaging operation in Windsor, CO. The role guides a 40–50 person team across three shifts, driving performance of highly automated packaging assets, improving OEE, changeovers, and throughput while ensuring GMP compliance.

You will partner with Engineering and Quality to address technical gaps, lead investigations, and develop automation business cases.

Qualifications

• 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.

Responsibilities

• 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

Job description

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 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
• On-site role in Windsor, Colorado
• Permanent, Full-time
• Benefits included