Technical Lead Engineer (3 Year FTC)
Core
Technical leadership for sterile injectable fill finish manufacturing, ensuring regulatory compliance, equipment reliability, and new product process development.
Role type
Senior IC manufacturing engineering lead (pharmaceutical)
Builds
Sterile fill finish manufacturing systems (cartridge, syringe, vial lines) and critical facility utilities
Domain
Healthcare / Pharmaceutical manufacturing
Deliverable
physical/clinical work
Required skills
Reliability engineering, GMP compliance, HVAC systems management, process development, equipment qualification, root cause analysis, Lean Manufacturing, Six Sigma
Preferred skills
Predictive maintenance, capital project management, technology transfer
Technologies
HVAC systems, Clean Steam, Water for Injection (WFI), Purified Water, Building Management Systems (BMS), Cartridge filling equipment, Syringe/Vial filling equipment
Responsibilities
Lead engineering activities for regulatory inspection readiness and GMP compliance; Provide technical leadership for HVAC, clean utilities, and facility infrastructure; Drive maintenance excellence and reliability programs for production assets; Serve as engineering lead for new cartridge filling line process development; Support qualification lifecycle documentation (DQ, IQ, OQ, PQ) for new equipment and systems.
Seniority
Senior, hands-on IC
