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