Instrumentation Specialist

Orano Med is seeking an Instrumentation Specialist for radiopharmaceutical manufacturing at ATLab Indianapolis ("ATLab IND"), a new facility for commercial-scale manufacturing of sterile therapeutic radiopharmaceuticals.

The Instrumentation Specialist will be responsible for maintaining, calibrating, and ensuring the accurate operation of critical laboratory instrumentation. This position presents the opportunity to help establish a new facility that will meet high standards for quantity, speed, and reliability.

Responsibilities

• Perform routine maintenance, calibration, and troubleshooting of HPLC systems, lab balances, particle counters, viable air samplers, BMS, and various sensors.

• Ensure all instrumentation operates within specified parameters and maintains accurate records of maintenance and calibration activities.

• Conduct temperature mapping for storage areas, equipment, and facilities to ensure compliance with regulatory requirements.

• Ensure all instrumentation activities comply with relevant regulatory standards (e.g., FDA, GMP, ISO).

• Diagnose and resolve technical issues with instrumentation, working with vendors and service providers as necessary.

• Remote work may be possible when the facility is under construction.

Production

• Top priority: Daily routine production.

• Follow EHS regulations/guidelines: NRC (ALARA), OSHA, EPA, chemical, waste disposal, state/local regulations, etc.

• Manufacturing activities following SOPs, using proper aseptic technique.

• Setup production; line clearance; clean/VPHP.

• Troubleshoot urgent problems.

• Identify, document, and communicate failures/near misses.

• Quality/continuous improvement.

• Adhere to SOPs, company policies, regulatory requirements, and laws.

• Quality/continuous improvement

Physical: Stand for 6+ hours, lift/move 50 lbs., and wear cleanroom PPE

Our Full-Time Benefits

• Competitive compensation
• Health, Dental, and Vision insurance - with generous employer contributions
• 401(k) with employer matching and contribution amounts

• Life insurance and Short- and Long-Term Disability insurance provided by the company
• Generous Paid Time Off and holiday schedules
• Numerous Training and Development opportunities

• and more...

Qualifications Required

Education

• Bachelor's degree in Chemistry, Engineering, or a related technical field.

Experience

• 3-5 years of experience working with laboratory instrumentation in a pharmaceutical or radiopharmaceutical environment.

• Cleanroom operations: gowning, cleaning, EM, aseptic technique.

• Experience with HPLC, Radiochemistry QC Instruments, Particle Counters, Lab Balances, Pipettes, Viable Air Samplers

Preferred Experience

• Strong understanding of instrument calibration, maintenance, and troubleshooting.
• Experience with BMS and Sensors + CMMS.
• Safety: occupational, laboratory, chemical, radiation
• Production of radiopharmaceuticals
• IT/IS: eBR, eQMS, EMS, etc.

Orano is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, national origin, age, disability, citizenship, veteran status, marital status, sexual orientation, gender identity, genetic predisposition or carrier status or any other characteristic protected by law.