Sr. Equipment Engineer
Core
Design, develop, improve, and support validation and life cycle management of process equipment for clinical and commercial radiopharmaceutical manufacturing, including custom Hot Cells, formulation, and filling lines.
Role type
Senior Equipment Engineer (Radiopharmaceutical Manufacturing)
Builds
Custom Hot Cells, formulation lines, and filling lines for novel radiopharmaceutical technologies
Domain
Biopharmaceutical / Radiopharmaceutical Manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
GMP manufacturing equipment engineering, equipment validation, regulatory standards compliance, engineering project management, deviation investigation, CAPA development, change control, vendor management, technical documentation (SOPs, URSs)
Preferred skills
cGMP Biopharmaceutical or Radiopharmaceutical environment experience, MS in Engineering, Robotics working knowledge, clinical or commercial drug product manufacturing experience
Technologies
Custom Hot Cells, formulation lines, filling lines, Robotics
Responsibilities
Account for continuous operation and maintenance of process equipment; Lead engineering expansion projects for innovative isotope and drug product manufacturing; Lead development and maintenance of departmental procedures; Support GMP manufacturing operations via deviation investigations and change control; Collaborate with Production, Quality, Digital IT, Validation, and Facility Engineering; Lead projects related to external vendors for novel equipment technologies; Comply with site EHS and Radiation Safety programs; Review and revise technical documents.
Seniority
Senior, hands-on IC
