Principal Engineer, Global Technical Operations, Engineering & Innovation
Core
Subject matter expert providing technical leadership in the design of isolated sterile fill finish and lyophilization equipment and supporting plant systems for biopharma companies.
Role type
Principal Engineer, Global Technical Operations
Builds
Front End Engineering Designs, project scopes, cost estimates, and schedules for sterile manufacturing assets
Domain
Biopharma / Contract Development and Manufacturing Organization (CDMO)
Required skills
Isolated sterile fill finish and lyophilization expertise, Front End Engineering Design management, cross-functional team leadership, segment-level standardization, Lean Manufacturing, capital project leadership, system requirements development, Factory/Site Acceptance Testing, risk and safety assessment
Preferred skills
cGMP engineering experience, CDMO environment experience, people supervision, procurement and vendor selection, continuous improvement ideation, aseptic processing
Technologies
Isolated environments, RABS, lyophilization systems, sterile fill finish equipment
Responsibilities
Manage external engineering partners and internal teams for Front End Engineering Designs; Develop and implement segment-level engineering standards; Lead Manufacturing Asset Assessments and Site Master Planning; Conduct troubleshooting and technical analyses on operational equipment; Establish project charters and governance structures; Lead implementation of major capital projects; Engage end users to develop system specifications and oversee fabrication/testing (via careerplan.io/jobs/JR119605-principal-engineer-global-technical-operations-engineering-innovation-at-pciservices)
Seniority
Principal, hands-on IC with strategic oversight