Senior Engineer, Equipment Engineering β report to Associate Director; lead equipment engineering projects supporting clinical and commercial manufacturing at Indianapolis site(s).
Job Responsibilities
- Ensure continuous operation and maintenance of radiopharmaceutical clinical/commercial process equipment.
- Lead engineering expansion projects for isotope and radiopharmaceutical drug product manufacturing.
- Develop and maintain departmental procedures/processes for equipment engineering.
- Support GMP operations: lead/contribute to deviation investigations, CAPA execution, and change control (on-call evenings/weekends).
- Collaborate with Production, Quality, Digital IT, Validation, and Facility Engineering for implementation of novel radiopharmaceutical technologies.
- Lead projects with external vendors/partners/service providers for novel isotope/drug product equipment.
- Comply with site EHS and Radiation Safety.
- Review/author/revise technical documents (SOPs, URS, forms, reports).
- Travel as required.
Education/Experience
- Minimum 5+ years engineering experience on equipment (required).
- Preferred: cGMP biopharmaceutical/radiopharmaceutical or medical device environment equipment engineering design/development/validation.
- Required: BS Engineering; Preferred: MS Engineering.
Skills/Requirements
- GMP equipment engineering (BioPharma or Medical Device).
- GMP/validation/regulatory standards and best practices.
- Project management; working knowledge of robotics.
- Experience in clinical/commercial drug or medical device manufacturing.
- Continuous improvement, ethics/confidentiality, organized/detail oriented, strong communication/time management.
- Ability to support manufacturing work under pressure; uses AI tools to improve productivity.
Benefits (as listed)
- Health coverage (medical/pharmacy/dental/vision); wellbeing support; 401(k), disability, life/accident, and related financial protections.
- Paid time off (flexible time off or 160 hours annual vacation depending on site/role) plus national holidays.
Physical/Work Conditions
- Laboratory + GMP environments; PPE and comfort working with radioactive materials; ability to lift 50 lbs and perform required physical activities.