Syringe Filling PCU Lead
Sanofi
August 20, 2026
On-site
Swiftwater, PA
$133,500 - $192,833.33 USD yearly
Operations
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.
Qualifications
- 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.
Preferred Qualifications/Skills
- 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 escalate operational issues appropriately.
- Leadership, communication, decision-making, conflict resolution, employee/team development.
- Business analysis, scheduling/planning, budget/headcount management, process improvement.
Special Working Conditions
- Ability to gown for entry to aseptic manufacturing areas.
- 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.
Qualifications
- 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.
Preferred Qualifications/Skills
- 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 escalate operational issues appropriately.
- Leadership, communication, decision-making, conflict resolution, employee/team development.
- Business analysis, scheduling/planning, budget/headcount management, process improvement.
Special Working Conditions
- Ability to gown for entry to aseptic manufacturing areas.