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Senior Facility Engineer

2 months ago

Totowa, New Jersey, United States SOFIE Full time

Position:
Facility and Equipment Engineer II

Location:
NJ5-Totowa, New Jersey

Department:
Radiopharmaceutical Contract Manufacturing

Overview:
The Facility and Equipment Engineer for Radiopharmaceutical Contract Manufacturing is dedicated to ensuring that the facility adheres to cGMP standards, 21 CFR 211, and all relevant Facility SOPs. This role is responsible for the maintenance, calibration, and operational integrity of all equipment and instrumentation within the manufacturing setting. The successful candidate will contribute significantly to a cutting-edge contract manufacturing facility that produces aseptically manufactured therapeutic and diagnostic radiopharmaceuticals.

Key Responsibilities:
  • Develop and manage the facility and equipment program in accordance with SOFIE standards, industry practices, and equipment manufacturer guidelines.
  • Oversee the operation, maintenance, calibration, and troubleshooting programs, including scheduling and work management for facility and equipment activities.
  • Coordinate with the Production Manager to plan shutdowns, ensuring resource availability for timely project completion and optimizing facility uptime.
  • Implement improvements to enhance line efficiencies and equipment maintenance performance.
  • Establish and monitor the equipment calibration program to align with operational objectives.
  • Ensure compliance with cGMP standards across all areas and equipment.
  • Engage with contractors for construction, renovation, validation, and other necessary activities.
  • Manage relationships with material and equipment vendors as needed.
  • Maintain an inventory of spare parts for all facility equipment.
  • Conduct quality investigations promptly regarding deviations, out-of-tolerance conditions, and unexpected results, performing failure analysis and root cause determination.
  • Drive continuous improvement initiatives by managing projects and recommending techniques to enhance equipment/system/process reliability.
  • Perform safety assessments for equipment modifications.
  • Oversee the facility security system, Environmental Monitoring System (EMS), and Building Management System (BMS).
  • Provide ongoing training to staff regarding facility and equipment operations.
  • Utilize engineering principles to address challenges and collaborate with production teams to implement corrective actions for optimizing uptime and quality.
  • Ensure timely completion of requested facility projects in collaboration with operations.
  • Maintain compliance with all relevant regulatory agencies.
  • Manage routine maintenance tasks, including general repairs and upkeep.
  • Maintain accurate records in accordance with SOPs.
  • Perform additional tasks as assigned.

Qualifications:
For Facility Engineer II, a bachelor's degree in a technical discipline (e.g., engineering or sciences) or 5 years of technical experience is required; for Facility Engineer I, 3+ years of technical experience is necessary. The ideal candidate will have 5+ years of combined experience in facilities management, manufacturing, or engineering and project management within an industrial production environment; for Facility Engineer I, 3+ years are required. Experience in the pharmaceutical industry is preferred.

Expertise in the operation and troubleshooting of utilities such as HVAC, high purity water, high purity gas, and process heating/cooling is essential. Experience with process equipment operation and maintenance is required. Candidates must be able to work safely in environments with hazardous chemicals and high-pressure systems. Availability for after-hours work and on-call duties is necessary. Proficiency in laboratory information management systems (LIMS) and Computerized Maintenance Management Software (CMMS) is desirable. Excellent verbal and written communication skills are essential.