Sterile Engineer, Specialist (On-site)
Core
On-site engineering support for sterile operations, equipment reliability, maintenance, and validation within a pharmaceutical research and manufacturing facility.
Role type
Senior IC Sterile Manufacturing Engineer
Builds
Sterile drug products (clinical, stability, developmental) via aseptic filling and formulation
Domain
Pharmaceutical manufacturing / Sterile processing
Required skills
cGMP compliance, Sterile manufacturing equipment knowledge, Equipment lifecycle management, Validation documentation, Troubleshooting (mechanical/electrical/automation), Capital project support, Quality Engineering principles, Asset management, Regulatory inspection support
Preferred skills
CMMS proficiency, SAP Plant Maintenance, eVal/Kneat, ProCal, Planning and Scheduling, Independent problem-solving
Technologies
CMMS, SAP, eVal, Kneat, ProCal
Responsibilities
Support equipment commissioning, qualification, and lifecycle management; Author and review validation protocols and reports; Manage equipment changes and deviations; Oversee contractor and vendor activities; Support capital projects and budget administration; Ensure GMP and safety compliance
Seniority
Mid-level, hands-on IC