Senior Facility and Equipment Engineer

2 weeks 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 operates in accordance with current Good Manufacturing Practices (cGMP), 21 CFR 211, and all relevant Standard Operating Procedures (SOPs). This role involves 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, producing aseptically created therapeutic and diagnostic radiopharmaceuticals.

Key Responsibilities:
  • Develop and manage the facility and equipment program in alignment with SOFIE standards, industry practices, and equipment manufacturer guidelines.
  • Oversee the operation, maintenance, calibration, and troubleshooting initiatives, including scheduling and work coordination related to facility and equipment activities.
  • Collaborate with the Production Manager to plan shutdowns, ensuring resource availability for timely task completion and optimizing facility uptime.
  • Implement enhancements to address line inefficiencies and improve equipment maintenance performance.
  • Establish and oversee the equipment calibration program to achieve operational objectives.
  • Ensure compliance with cGMP across all areas and equipment.
  • Manage contractor interactions for construction, renovation, validation, and other necessary activities.
  • Maintain spare parts inventory for all facility equipment.
  • Conduct timely quality investigations into deviations, out-of-tolerance conditions, and unexpected results, performing failure analysis and root cause determination.
  • Drive continuous improvement initiatives by managing projects and recommending strategies to enhance equipment/system/process reliability.
  • Conduct 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 resolve issues, collaborating with production to implement corrective actions that optimize uptime and quality.
  • Interface with operations to ensure timely completion of requested facility projects.
  • Ensure adherence to all applicable regulatory requirements, including those from FDA, OSHA, DOH, EPA, and local health departments.
  • Manage routine maintenance tasks, including general repairs and cleaning, as assigned.
  • Maintain accurate records in accordance with SOPs.
  • Perform additional tasks as assigned.

Qualifications:
For the Facility Engineer II role, a bachelor's degree in a technical discipline (e.g., engineering or sciences) or equivalent technical experience of 5 years is required. Candidates should possess a minimum of 5 years of combined experience in facilities management, manufacturing, or engineering and project management within an industrial production environment. 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 demonstrate the ability 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.

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