Senior Director, On-Site Pharmaceutical Packaging

Institute of Packaging Professionals; Windsor (CO); Presencial; USD 150.000 - 210.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Benefits included

Descripción de la vacante

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.

Formación

• 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.

Responsabilidades

• 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

Descripción del empleo

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.