Syringe Filling PCU Lead

Main Responsibilities

• Provide leadership, direction, and oversight of Line 7 Syringe Filling Process Centric Unit (PCU) for B57 Aseptic filling at the Swiftwater site; ensure 24-hour performance across all shifts (safety, quality, supply, financial results).
• Lead and develop a team of managers; manage ~35–45 team members across 3 shifts.
• Ensure facilities/equipment are properly maintained and verify continued validated state of equipment and processes.
• Ensure timely, high-quality completion of Deviations, Change Controls, CAPAs, and regulatory commitments; meet FDA/International Regulatory Body/Corporate Quality requirements; lead operational audits.
• Ensure shop floor safety and quality; partner with QA and Maintenance to address issues in real time; build cross-functional relationships.
• Drive aseptic processing best practices and SMS 2.0 ways of working to improve Filling OEE, unit success rate, and reduce costs; guide Asset Care/CI/Deviation meetings and maintain required metrics/cycle times.
• Support special projects related to integration of buildings, equipment, and processes; provide day-to-day support for short-term projects.
• Set departmental objectives aligned to site vision (safety, quality, productivity, cost, continuous improvement, employee involvement); ensure associates have what they need to work safely.
• Resolve problems/introduce changes; set performance standards; evaluate and develop direct reports; provide career development, training, goals, and regular feedback.
• Manage headcount and departmental expenses to achieve site objectives and meet budget expectations.

• Minimum:
  High School Diploma + 7+ years in a cGMP aseptic manufacturing environment; 3+ years leading teams.
• Preferred:
  Bachelor’s degree (Business/Engineering/Life Sciences or related) + 3+ years cGMP aseptic experience and 1+ years leading teams.
• Strong understanding of quality systems; strong knowledge of cGMP and regulatory requirements; experience in controlled/pharmaceutical industry.

• Manage multiple production priorities while maintaining quality/compliance.
• Experience with external regulator inspections.
• Cross-functional experience (Quality, Manufacturing Excellence, MSAT, Facilities, Engineering, Validation).
• Review SOPs/on-the-job trainings and other controlled documents.
• Troubleshooting, investigations (GPS), root cause and risk analysis in cGMP.
• Ability to escalating operational issues appropriately.
• Leadership, communication, decision-making, conflict resolution, employee/team development.
• Business analysis, scheduling/planning, budget/headcount management, process improvement.

• Ability to gown for entry to aseptic manufacturing areas.