Principal Engineer - Sterile Fill & Global Ops Leader

PCI TRGR Penn Pharmaceutical Services Ltd; Bedford (NH); On-site; USD 180,000 - 240,000; Full time

Job summary

PCI Pharma Services seeks a Principal Engineer for Global Technical Operations, Engineering & Innovation. Lead FEEDs for sterile fill/finish and lyophilization, coordinating cross-functional teams and external partners to deliver compliant, cost-effective projects.

The role drives standardization, Lean Manufacturing, and continuous improvement while partnering with Senior Leadership to support capital planning and site master planning.

Qualifications

• BS in Chemical/Mechanical engineering (accredited).
• PMP certification or similar accreditation.
• MS in Engineering preferred.
• 15+ years in cGMP engineering, facilities, utilities in biotech/pharma (CDMO)
• 10+ years in life science CDMO environment.
• 5+ years people supervision/management.
• 5+ years procurement/negotiation experience.
• 5+ years continuous improvement/ ideation platforms.
• Experience in aseptic processing and aseptic fill/finish.
• Aseptic lyophilization experience.

Responsibilities

• Act as SME in isolated or RABS sterile fill finishing and lyophilization equipment and operations.
• Lead Front End Engineering Design efforts: scopes, cost estimates, schedules for business cases.
• Manage external partners and internal cross-functional teams to deliver FEEDs and standards.
• Drive standard work and governance; develop engineering standards across site.
• Develop and implement system requirements, procurement, and installations with vendors.
• Lead site Master Planning and Asset Assessments in alignment with enterprise priorities.
• Support gate processes, pre-construction activities, and project daily management.
• Ensure safety and regulatory compliance across projects.

Skills

SME

Project Management

Lean Manufacturing

Continuous Improvement

Aseptic processing

Lyophilization

RABS

Vendor management

Stakeholder management

GMP

Education

B.S. in Chemical or Mechanical Engineering

PMP certification

M.S. in Engineering (preferred)

Tools

Front End Engineering Design

Job description

PCI Pharma Services seeks a Principal Engineer for Global Technical Operations, Engineering & Innovation. Lead FEEDs for sterile fill/finish and lyophilization, coordinating cross-functional teams and external partners to deliver compliant, cost-effective projects.

The role drives standardization, Lean Manufacturing, and continuous improvement while partnering with Senior Leadership to support capital planning and site master planning.