Senior Engineer - Process & Equipment
Core
Senior Equipment Process Engineer responsible for performance, reliability, and lifecycle management of aseptic drug product filling equipment in a GMP regulated manufacturing facility.
Role type
Senior IC mechanical/electro-mechanical engineer (pharmaceutical manufacturing)
Builds
Secondary manufacturing activities including Formulation, Vial/Syringe Filling, Lyophilisation, and Packaging
Domain
Biopharmaceutical manufacturing (Drug Product Engineering)
Required skills
statistical analysis tools, continuous improvement methodologies, mechanical engineering, electro-mechanical systems, automation systems, root cause analysis, project management, change control, vendor management, spare parts management
Preferred skills
biopharmaceutical Formulation/Fill/Finish experience, Vial or Syringe Filling equipment support, technical writing, validation practices, new product introduction strategy, business area strategy development, contract negotiations
Technologies
statistical analysis tools, automation systems, GMP systems
Responsibilities
Monitor day-to-day equipment performance and trend analysis; lead technical root cause analysis and incident investigations; develop engineering documents and standard operating procedures; manage change control requests; support new product introductions with engineering assessments; maintain structured maintenance schedules and spare parts lists; manage vendor support and contract negotiations
Seniority
Senior, hands-on IC
