Engineering Specialist

Role Summary

Engineering Specialist at Advanced Accelerator Applications, a Novartis company. The role focuses on executing engineering activities in maintenance, calibration, and commissioning to support site/project objectives. Location: Onsite.

Responsibilities

• Adhere to quality policies and procedures to ensure safe, pure, effective products of the highest quality.
• Perform maintenance and 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 including containment isolator systems and filling line equipment.
• Interpret P&IDs, equipment layouts, wiring diagrams, and specifications for planning maintenance and repairs.
• Support 24x7 site-based operations after startup.
• Write or revise operational procedures, training documents, and maintenance procedures for production and utility systems.
• Provide radiation safety program support and calibration of radiation detection equipment.
• Complete equipment work orders accurately and document in the system.
• Supply information and data for spare parts.
• Provide responsive customer support and maintain customer satisfaction.
• Perform startup and commissioning activities as required.
• Support investigations/deviations from an engineering/maintenance perspective and assist with timely closure of CAPAs.
• Perform preventative and corrective maintenance on manufacturing process equipment in a cleanroom environment.
• Complete and provide accurate documentation as required in cGMP operations.
• Oversee work and train less experienced maintenance technicians and/or new technicians.
• Other related duties as assigned.
• Use CMMS system for documentation of relevant work.

Qualifications

• High School diploma or equivalent required; bachelor's degree preferred.
• 3+ years of relevant hands-on plant maintenance experience in a regulated GMP environment.
• Previous supervisory or team/project lead experience preferred.
• Previous aseptic fill/finish and/or radiopharmacy experience preferred.
• Previous pharmaceutical or medical device experience preferred.
• Completed training in radioactive or hazardous materials environment preferred.
• Ability to adhere to procedures, policies, and quality/regulatory requirements (OSHA, DEA, FDA, EMEA, ANVISA, HS&E, etc.).
• Strong teamwork, communication, and organizational skills.
• Proficient in MS Office, Building Management Systems, and CMMS or similar systems.
• Ability to climb ladders and lift up to 50 lbs.
• Wearing protective clothing including respiratory protection; capable of working in clean rooms and confined spaces.
• Flexibility to work nights, weekends, and holidays as required.