Role Summary
Location: Framingham, MA. Hours: 7 am – 7 pm rotation. The Clean Utilities Maintenance Technician will perform daily operations, maintenance, troubleshooting, and repairs on clean utility systems that directly support manufacturing. This role requires technical expertise, strong problem-solving skills, and the ability to work independently while ensuring compliance with regulatory, corporate, and site requirements.
Responsibilities
- Operate, monitor, troubleshoot, and repair clean utility systems including WFI, Reverse Osmosis/Deionized (RODI) water, Clean Steam, Clean-In-Place (CIP) systems, autoclaves, glassware washers, and related process support equipment.
- Perform preventative and corrective maintenance on clean utility systems to ensure consistent, reliable, and compliant performance.
- Respond to alarms, perform daily walkthroughs, and maintain system performance within established parameters.
- Interpret P&IDs, system drawings, wiring diagrams, and technical specifications to plan and execute maintenance activities.
- Document maintenance activities in compliance with cGMP requirements, including work orders, PMs, and calibration/verification records.
- Collaborate with Engineering, Validation, Metrology, and Quality Assurance to support investigations, projects, and system improvements.
- Support commissioning, qualification, and system change control activities as required.
- Provide responsive customer support to manufacturing operations with an emphasis on reliability and compliance.
- Mentor and provide guidance to less experienced technicians on clean utilities operations and best practices.
Qualifications
- Required: High School Diploma or GED with 3–7 years of experience maintaining and operating clean utility systems (WFI, RODI, Clean Steam) in a cGMP or other regulated environment.
- Required: Strong knowledge of mechanical systems supporting clean utilities, including pumps, heat exchangers, valves, instrumentation, and controls.
- Required: Ability to read and interpret schematics, P&IDs, and loop diagrams.
- Required: Proficiency with CMMS systems, Building Management Systems (BMS), and/or Distributed Control Systems (DCS).
- Required: Strong written and verbal communication skills.
- Required: Ability to work independently with minimal supervision in a 24x7 regulated manufacturing environment.
- Required: Proficient in MS Office applications and general computer skills.
- Preferred: Prior experience supporting clean utility operations in a biotech or pharmaceutical manufacturing environment.
- Preferred: Familiarity with predictive maintenance technologies such as infrared thermography, vibration analysis, or ultrasonic testing.
- Preferred: Licensure in a relevant trade (e.g., wastewater treatment, plumbing, refrigeration, or electrical) is a plus.
Skills
- Ability to interpret technical documents (P&IDs, schematics, wiring diagrams).
- Strong problem-solving and independent work capabilities in a regulated environment.
- Effective collaboration with cross-functional teams (Engineering, Validation, Metrology, QA).
Education
- High School Diploma or GED
Additional Requirements
- Requires working in a cleanroom or controlled environment, including gowning.
- May require working 12-hour rotating shifts, including weekends and holidays.
- Ability to climb ladders, work in tight spaces, and lift up to 50 lbs.