Engineering & Maintenance Technician I/II

Role Summary

Engineering & Maintenance Technician I/II at a GMP Radioligand Therapies Production Facility. Responsible for corrective and preventative maintenance and support services for building(s) and equipment, ensuring reliable, efficient operation and compliance with regulatory, corporate, and site requirements. Location: Onsite. Shift may be adjusted to 1st or 2nd after onboarding.

Responsibilities

• Adhere to quality policies and procedures to ensure products are safe, pure, and of high quality.
• Perform maintenance and repair activities on production equipment, lab equipment, and building management systems.
• Troubleshoot and repair process equipment (e.g., containment isolator systems, filling line equipment, utility connections) with limited supervision.
• Interpret P&IDs, equipment/system layouts, wiring diagrams, and specifications for planning and repairs.
• Support 24x7 site-based operations after startup.
• Write/revise operational procedures, training documents, and maintenance procedures for production and utility systems.
• Provide radiation safety program support and calibrate/determine functionality of radiation detection equipment.
• Complete equipment work orders accurately and document in the system.
• Supply technical data for spare parts.
• Provide responsive customer support with emphasis on satisfaction.
• Perform startup and commissioning activities as required.
• Support investigations/deviations from an engineering/maintenance perspective and assist with data for timely closure of CAPAs.
• Perform preventative and corrective maintenance on manufacturing process equipment in cleanroom environments.
• Complete and provide accurate documentation as required in cGMP operations.
• Oversee work and train less experienced maintenance technicians.
• Other related duties as assigned.
• Use CMMS system for documentation of relevant work.

Qualifications

• Engineering & Maintenance Technician I:
  • High School diploma or equivalent required; Bachelor's degree preferred.
  • 1+ years of hands-on plant maintenance experience in a regulated GMP environment required.
  • 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 and 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 system.
  • Ability to climb ladders and lift up to 50 lbs.
  • Wearing protective clothing, including respiratory protection, confined space entry, and clean room environments.
  • Flexible to work nights, weekends, and holidays; shift-based.
• Engineering & Maintenance Technician II:
  • High School diploma or equivalent required; Bachelor's degree preferred.
  • 2+ years of hands-on plant maintenance experience in a regulated GMP environment required.
  • Previous pharmaceutical or medical device experience required.
  • Previous aseptic fill/finish and/or radiopharmacy experience highly preferred.
  • Completed training in radioactive or hazardous materials environment highly preferred.
  • Ability to adhere to procedures and 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 system.
  • Ability to climb ladders and lift up to 50 lbs.
  • Wearing protective clothing, including respiratory protection, confined space entry, and clean room environments.
  • Flexible to work nights, weekends, and holidays; shift-based.

Skills

• Maintenance and repair of production, lab, and utility equipment
• Troubleshooting electrical, mechanical, pneumatic, and control systems
• Reading P&IDs, wiring diagrams, and specifications
• Operational procedures writing and documentation
• Radiation safety program support and detector calibration
• CMMS documentation and spare parts management
• Effective communication and customer service

Education

• High School diploma or equivalent required; Bachelor‚Äôs degree preferred for both Technician I and II roles.

Additional Requirements

• Ability to work in a cleanroom environment and wear protective clothing
• Ability to work in a regulated GMP environment and adhere to applicable regulatory requirements
• Onsite location with shift-based schedule (1st or 2nd)