Syringe Filling PCU Lead (Aseptic Manufacturing)

Location: Swiftwater, Pennsylvania, United States; onsite role in an aseptic manufacturing facility

Salary: $133,500–$192,833.33 per year

Company

hirify.global is an R&D-driven, AI-powered biopharmaceutical company developing medicines and vaccines to improve health outcomes worldwide.

What you will do

• Lead the Line 7 Syringe Filling Process Centric Unit for B57 aseptic filling across all shifts.
• Own safety, quality, supply, financial performance, equipment maintenance, and validated processes within the assigned area.
• Ensure deviations, change controls, CAPAs, audits, and regulatory commitments are completed on time and meet FDA, international, and corporate quality requirements.
• Partner with QA, Maintenance, Manufacturing Excellence, MSAT, Facilities, Engineering, and Validation to resolve operational issues and support production.
• Implement aseptic-processing best practices and SMS 2.0 ways of working to improve filling OEE, unit-operation success rates, compliance, and costs.
• Manage, develop, and evaluate a 35–45-person team across three shifts, including headcount, expenses, performance standards, training, and career development.

Requirements

• High school diploma plus 7+ years of experience in a cGMP aseptic manufacturing environment and 3+ years leading teams; or a bachelor’s degree in business, engineering, life sciences, or a related field plus 3+ years of cGMP aseptic manufacturing experience and 1+ year leading teams.
• Strong understanding of quality systems, cGMP, regulatory requirements, and controlled pharmaceutical manufacturing environments.
• Experience with scheduling and planning, budget and headcount management, business analysis, and process improvement.
• Ability to manage multiple production priorities while maintaining quality, compliance, and manufacturing schedules.
• Ability to gown for entry to aseptic manufacturing areas.

Nice to have

• Experience with external regulatory inspections and reviewing SOPs, on-the-job training materials, and controlled documents.
• Experience with troubleshooting, investigations, root-cause analysis, and risk analysis in a cGMP environment.
• Experience working with cross-functional manufacturing and validation teams.

Culture & Benefits

• Supportive, future-focused environment centered on science, medicines, vaccines, and global supply resilience.
• Career growth opportunities through promotions and international or lateral moves.
• Employee rewards and benefits, including healthcare, prevention and wellness programs, and at least 14 weeks of gender-neutral parental leave.
• Opportunities to use digital, data, and AI-driven innovation in pharmaceutical manufacturing.