The Engineering Technician is responsible for performing maintenance functions on equipment and facilities at
the SOFIE's NJ5 (Totowa) pharmaceutical manufacturing site. This requires a job knowledge of working in a cGMP
environment and following safety regulations. Following SOFIE’s SOPs, and QMS requirements, and cGMP guidelines, the
Engineering Technician will ensure maintenance activities are performed and documented in full compliance with all
regulatory requirements, including 21 CFR 211 and Eudralex Volume 4, and all other applicable regulations for drug
manufacturing.
Essential Duties and Responsibilities
- Operate and maintain site-based utility, electrical, HVAC and facility systems, including soft water system, chillers,
boilers, compressed gases, air handling units, controlled temperature unit (CTU), switchgear, emergency
generators, fire protection and building management and control systems.
- Monitors and operates the Building Management System (BMS) and Environmental Monitoring System (EMS).
- Lead initial alarm response of BMS, system owner notification, and correction of alarm condition.
- Perform routine, non-routine, scheduled, and emergency maintenance in a safe manner while meeting all quality
requirements following site SOPs & Procedures.
- Complete documentation related to maintenance activities per work instructions, including preventative
maintenance, repair, and audit logs in compliance with SOFIE SOP’s.
- Perform routine review of equipment status according to scheduled inspections and report findings.
- Plan and execute maintenance activities on a schedule determined by the Facility Engineering team. Update
maintenance logs upon completion of services.
- Install, maintain, troubleshoot and repair motors, pumps, valves, filters, compressors, switches, dampers, fans,
piping, transmitters, vessels, safety devices and other components that support the sites operation (production,
quality, distribution of patient materials).
- Provide timely notification to supervisors regarding equipment corrective maintenance requirements, operation and
status.
- Provide first-line response in maintaining and repairing all manufacturing equipment at the facility, including process
specific isolators, master-slave manipulator arms, Bio Safety Cabinet, HEPA filters, and all equipment used for both
manufacturing and support systems.
- With the Facility Engineer/Manager, oversee the work of all third-party contractors on equipment related to
manufacturing.
- Perform radiation safety duties to SOFIE Radiation Compliance/Environmental Health and Safety Program
standards to ensure compliance with all regulations under the Corporate and site RSO.
- Ensure compliance with all procedures and regulations within the site under the Quality Assurance program as
applicable, including participating in exception document reporting (e.g. deviations, corrective and preventative
action plans, out-of-specifications, etc.)
- Routinely perform work in Grade D through C classification rooms and Grade A environments.
- Provide technical training and support for other employees on use, operation and maintenance of equipment.
- Provide after-hour on-call support to the site in addition to weekend work on as need basis.
- Submit all work orders, timecards, and expense reports in a timely manner.
- Maintain stock of spare parts and generate inventory reports for those items.
- Help metrologist to perform on time site equipment/instrument calibration.
- Support biannual facility shutdown and preventative maintenance activity.
- Perform other tasks/duties as assigned
