Engineering Specialist

Job Description Summary

At Advanced Accelerator Applications, a Novartis company, we are committed to leading innovation in nuclear medicine and delivering the next generation of targeted radioligand therapy to cancer patients. We are looking for experienced Manufacturing professionals to help us reach our ambitious goals.

The Engineering Specialist will execute engineering activities (design, implementation, maintenance, etc.) within the technical area of expertise using reliable and cost‑effective solutions, ensuring technical quality to enable overall site / project objectives. Responsible for execution of maintenance, calibration and commissioning activities for projects at site level.

• Adhere to Novartis Quality Policies and procedures to ensure all products are safe, pure, effective and of the highest quality.
• Perform a wide range of maintenance, repair activities on production equipment, lab equipment and building management systems.
• Provide guidance and leadership to team members.
• Assist in troubleshooting and repair of process equipment (e.g., containment isolator systems, filling line equipment and associated utility connections) which may include mechanical, electrical, wiring, pneumatics, motors, pumps, vacuum systems, HVAC, control systems, compressed gases, filling line, under little to no supervision.
• Interpret P&IDs, equipment/system layouts, wiring diagrams, and specifications in planning and performing maintenance and repairs.
• Support 24x7 site‑based operations after startup.
• Write/revise accurate operational procedures, training documents and maintenance procedures for various production and utility systems.
• Provide radiation safety program support, responsible for calibration and functionality of all radiation detection equipment.
• Complete equipment work orders thoroughly, accurately and document them in the system.
• Supply information and technical data for securing spare parts.
• Provide responsive customer support with emphasis on customer satisfaction.
• Perform startup and commissioning activities as required.
• Support and/or perform investigations/deviations from an engineering/maintenance perspective and help with data for timely closure of deviations and CAPAs.
• Perform preventative and corrective maintenance on manufacturing process‑related equipment within a cleanroom environment.
• Complete and provide accurate documentation, as required in cGMP operations.
• Oversee work and provide training of less experienced maintenance technicians and/or new technicians.
• Other related duties as assigned.
• Use CMMS system for documentation of relevant work.

Expected range: $85,400 – $158,600 per year. Compensation includes a performance‑based cash incentive and eligibility for annual equity awards. US‑based eligible employees receive a comprehensive benefits package included health, life, disability, 401(k) with company match, time off, vacation, holidays, and other leaves.

• High School diploma or equivalent required; bachelor’s degree preferred.
• 3+ years of relevant hands‑on plant maintenance experience in a regulated GMP environment required.
• Previous supervisory, team/project lead experience preferred.
• Previous aseptic fill/finish and/or radio pharmacy experience preferred.
• Previous pharmaceutical or medical device experience preferred.
• Completed training in radioactive or hazardous materials environment preferred.
• Must adhere to all applicable procedures, company policies and any other quality or regulatory requirements (e.g., OSHA, DEA, FDA, EMEA, ANVISA, HS&E).
• Experience working in a team environment with excellent communication and organizational skills.
• Proficient computer skill utilizing MS Office suite applications, Building Management Systems, and CMMS or similar system.
• Ability to climb ladders and lift up to 50 lbs.
• Wear and work in protective clothing, including respiratory protection, confined space entry and cleanroom environments.
• Must be flexible to work nights, weekends, and holidays as required.

The Novartis Group of Companies are Equal Opportunity Employers. We do not discriminate in recruitment, hiring, training,…