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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:
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 involves the maintenance, calibration, and verification of all equipment and instrumentation within the manufacturing environment. The successful candidate will contribute significantly to a cutting-edge contract manufacturing facility that produces aseptically manufactured therapeutic and diagnostic radiopharmaceuticals.

Key Responsibilities:
1. Develop and manage the facility and equipment program in accordance with industry standards and equipment manufacturer guidelines.
2. Oversee the operation, maintenance, calibration, and troubleshooting programs, ensuring timely scheduling and resource availability.
3. Collaborate with the Production Manager to coordinate shutdowns for optimal facility uptime.
4. Implement enhancements to improve operational efficiency and equipment maintenance performance.
5. Establish and monitor the equipment calibration program to align with operational objectives.
6. Ensure compliance with cGMP across all areas and equipment.
7. Engage with contractors for construction, renovation, validation, and other necessary activities.
8. Maintain spare parts inventory for all facility equipment.
9. Conduct quality investigations regarding deviations and unexpected results, performing failure analysis and root cause determination.
10. Drive continuous improvement initiatives by managing projects and recommending strategies to enhance equipment/system/process reliability.
11. Conduct safety assessments for equipment modifications.
12. Oversee the facility security system, Environmental Monitoring System (EMS), and Building Management System (BMS).
13. Provide ongoing training to staff on facility and equipment operations.
14. Utilize engineering principles to address challenges and work closely with production to optimize performance.
15. Ensure timely completion of facility projects in collaboration with operations.
16. Maintain compliance with all applicable regulatory agencies.
17. Manage routine maintenance tasks and maintain accurate recordkeeping as per SOPs.
18. Perform additional duties as assigned.

Qualifications:
1. Bachelor’s degree in a technical discipline (e.g., engineering or sciences) or 5 years of technical experience required.
2. Minimum of 5 years of combined experience in facilities management, manufacturing, or engineering in an industrial production setting.
3. Preferred experience in the pharmaceutical industry.
4. Proficiency in the operation and troubleshooting of utilities such as HVAC, high purity water, and process heating/cooling.
5. Experience with process equipment operation and maintenance is essential.
6. Ability to work safely in environments with hazardous materials.
7. Willingness to work after hours and be on call as necessary.
8. Familiarity with Equipment Monitoring Systems and Building Management Systems is required.
9. Proficiency in laboratory information management systems (LIMS) and Computerized Maintenance Management Software (CMMS) is desirable.
10. Strong verbal and written communication skills are essential.