Engineering Technician

This role is based at SOFIE’s NJ5 (Totowa) pharmaceutical manufacturing site and requires working in a cGMP environment while adhering to safety regulations, SOPs, QMS requirements, and cGMP guidelines. The Engineering Technician ensures all maintenance activities comply with regulatory standards, including 21 CFR 211 and Eudralex Volume 4.

Responsibilities

• Operate and maintain site-based utility, electrical, HVAC, and facility systems, including soft water systems, chillers, boilers, compressed gases, air handling units, controlled temperature units (CTU), switchgear, emergency generators, fire protection, and building management and control systems.
• Monitor and operate the Building Management System (BMS) and Environmental Monitoring System (EMS).
• Lead initial alarm response for BMS, notify system owners, and correct alarm conditions.
• Perform routine, non-routine, scheduled, and emergency maintenance safely while adhering to site SOPs and quality requirements.
• Complete documentation for maintenance activities, including preventative maintenance, repairs, and audit logs in compliance with SOFIE SOPs.
• Conduct routine equipment inspections and report findings.
• Plan and execute maintenance activities on a schedule set by the Facility Engineering team and update maintenance logs upon completion.
• Install, maintain, troubleshoot, and repair motors, pumps, valves, filters, compressors, switches, dampers, fans, piping, transmitters, vessels, safety devices, and other components supporting site operations.
• Provide timely notifications to supervisors regarding equipment corrective maintenance needs, operational status, and issues.
• Maintain and repair all manufacturing equipment, including process-specific isolators, master-slave manipulator arms, Bio Safety Cabinets, HEPA filters, and support systems.
• Oversee third-party contractors working on manufacturing-related equipment in collaboration with the Facility Engineer/Manager.
• Perform radiation safety duties in compliance with SOFIE’s Radiation Compliance/Environmental Health and Safety Program and corporate/site RSO regulations.
• Ensure compliance with site Quality Assurance procedures, including participating in exception document reporting (e.g., deviations, corrective and preventative action plans, out-of-specifications).
• Work routinely in Grade D through C classification rooms and Grade A environments.
• Provide technical training and support to other employees on equipment use, operation, and maintenance.
• Provide after-hours on-call support and weekend work as needed.
• Submit work orders, timecards, and expense reports in a timely manner.
• Maintain spare parts inventory and generate inventory reports.
• Assist the metrologist with on-time site equipment/instrument calibration.
• Support biannual facility shutdowns and preventative maintenance activities.
• Perform other assigned tasks and duties.

Requirements

• Associate’s Degree in Engineering Technology or a related skilled trade field, or 3 years of relevant work experience with utility, HVAC, or electrical systems in biotech/pharma/laboratory or other regulated industries.
• Proficiency in MS Office applications.
• Ability to analyze, investigate, and resolve technical equipment issues, including monitoring Building Management Systems.
• Ability to read and interpret mechanical and electrical drawings.
• Flexibility to accommodate all shifts and holidays.
• Basic knowledge of analytical equipment and proficiency in maintaining manufacturing areas and equipment.
• Ability to lift up to 50 pounds and climb ladders.
• Experience with hazardous materials, including radioactive materials, and knowledge of radiation safety is a plus.
• Military training/experience is a plus.
• Knowledge of lockout/tagout processes required.
• Knowledge of basic cGMP practices and procedures is a plus.
• Occupational exposure to low-level ionizing radiation required.
• Travel: up to 10%.
• OSHA – 10 Hour training is a plus.

Pay

$32–$34 per hour.