Sr. Equipment Engineer
Core
Design, develop, improve, and support validation and life cycle management of process equipment for novel radiopharmaceutical technologies, including custom Hot Cells, formulation, and filling lines.
Role type
Senior Equipment Engineer (Radiopharmaceutical Manufacturing)
Builds
Clinical and commercial manufacturing of radiopharmaceutical drug products
Domain
Biopharmaceutical / Radiopharmaceutical / Oncology
Required skills
GMP manufacturing equipment engineering, Equipment design and validation, Project management, Robotics knowledge, Deviation investigation and CAPA, Change control, Vendor management, Technical documentation (SOPs, URS), Radiation safety compliance
Preferred skills
cGMP Biopharmaceutical or Radiopharmaceutical environment experience, MS in Engineering, Clinical or commercial manufacturing of drug products
Technologies
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