Facility and Equipment Engineer II at SOFIE

Title: 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 committed to
ensuring the facility is maintained in compliance with cGMP, 21 CFR 211, and all Facility SOPs. They maintain, calibrate,
and ensure proper operation of all equipment and instrumentation in the manufacturing environment. This role provides
critical support in a state-of-the-art contract manufacturing facility, manufacturing aseptically produced therapeutic and
diagnostic radiopharmaceuticals. The successful candidate will play an active and integral part of the RCM team.

Essential Duties and Responsibilities

Develop and oversee the facility and equipment program per standards set by SOFIE, the industry, and
equipment manufacturer’s recommendations.
▪ Develop and oversee the operation, maintenance, calibration, and troubleshooting programs, including
scheduling, work for facility and equipment with respect to aforementioned activities. Coordinate shutdowns with
the Production Manager to ensure the availability of resources for timely completion and to optimize facility uptime.
▪ Implement changes to improve line inefficiencies and equipment maintenance performance under the Production
Manager.
▪ Develop and monitor the equipment calibration program to meet operational goals.
▪ Ensure that all areas and equipment are maintained under cGMP.
▪ Interact with and manage contractors for construction, renovation, validation, and other activities as required.
Coordinate with material/equipment vendors as required.
▪ Maintain the spare parts inventory for all facility equipment
▪ Perform quality investigations in a timely manner regarding deviations, out of tolerance conditions, unexpected
results on facility issues by conducting failure analysis, root cause determination, and corrective action
determination.
▪ Drive continuous improvement by managing projects and recommending techniques to enhance
equipment/system/process robustness and maintain the facility in peak condition.
▪ Carry out safety assessments for modifications to equipment.
▪ Oversee and maintain the facility security system, Environmental Monitoring System (EMS), and Building
Management System (BMS).
▪ Develop and deliver ongoing training to staff regarding the facility and equipment.
▪ Utilize facility engineering principles to solve problems. Work with production on a daily basis to coordinate
appropriate corrective actions to optimize up-time and quality performance of respective area.
▪ Interface with operations to complete requested facility projects in a timely manner.
▪ Ensure compliance with all applicable regulatory agencies including FDA, OSHA, DOH, EPA, fire department,
local codes, health department, etc.
▪ Manage routine maintenance tasks including general building repairs, painting, office furniture installation,
cleaning, etc. as assigned. Initiate and complete work orders.
▪ Maintain accurate recordkeeping per SOPs.
▪ Perform other tasks/duties as assigned.

Qualifications
▪ For Facility Engineer II, bachelor’s degree, preferably in technical discipline (e.g., engineering or sciences) or 5
years technical equivalence required; for Facility Engineer I, 3+ years technical equivalence required.
▪ For Facility Engineer II, 5+ years combined experience in areas of facilities management, manufacturing, or
engineering and project management in an industrial production environment required; for Facility Engineer I, 3+
years required.
▪ Pharmaceutical industry experience preferred. 

▪Expertise in operation and troubleshooting/repair of utilities such as HVAC, high purity water, high purity gas, and process heating/cooling required.
▪ Experience with process equipment operation and maintenance required.
▪ Ability to work safely in an environment containing hazardous chemicals, high and low temperature liquids, and
high-pressure liquids and gases required.
▪ Able to work after hours and on call as needed required.
▪ Ability to check and respond to Equipment Monitoring System and Building Management Systems required.
▪ Proficiency in laboratory information management systems (LIMS) and Computerized Maintenance Management
Software (CMMS) desired.
▪ Excellent verbal and written communication skills required.