Senior Maintenance Technician

This role ensures equipment, utilities, and cleanroom environments remain in a validated state, supporting reliable, compliant, and safe operations. The technician partners closely with Manufacturing, Quality, and Engineering to execute preventive and corrective maintenance, lead troubleshooting, drive continuous improvement, and mentor junior technicians. 
 

Essential Functions and Responsibilities  

• GMP Maintenance Execution: Perform and document preventive, predictive, and corrective maintenance on cell therapy process equipment. 

•  Cleanroom Support: Perform maintenance activities in ISO-classified environments while following gowning, aseptic behavior, contamination-control, and environmental monitoring requirements. Coordinate with Quality and Engineering to protect the validated state during maintenance and equipment return-to-service. 

•  Troubleshooting & Root Cause Analysis: Perform equipment and utility troubleshooting; use cGMP investigations, 5-Why/Fishbone, and data from EMS and CMMS to determine root cause; implement effective CAPAs in collaboration with QA and Engineering. 

•  Documentation & Compliance: Complete GMP documentation contemporaneously and accurately (work orders, logs, forms, deviations, change controls, calibration records); follow GDP, SOPs, and site policies; support audits and regulatory inspections. 

•  Calibration & Metrology: Perform or coordinate calibration of critical instruments (pressure, temperature, flow, mass, conductivity, pH, CO2, RH); maintain standards, certificates, and traceability to NIST or equivalent. 

•  Validation Support: Partner with Engineering/Validation on equipment qualification (URS/IQ/OQ/PQ), requalification, and change control; execute test protocols and record data per validation requirements, including for clean steam and purified utility systems. 

•  Asset & CMMS Management: Use CMMS to plan, prioritize, and close work; optimize PM/PdM plans, spare parts inventories, and equipment hierarchies; track KPIs (MTBF, MTTR, schedule compliance). 

•  Safety & EHS: Champion a strong EHS culture; perform LOTO, permit-to-work (hot work, confined space), chemical and gas handling, and electrical safety; conduct risk assessments and JHAs; ensure compliance with OSHA, NFPA 70E, and local regulations. Adhere to boiler codes and water treatment/Legionella control plans. 

•  Continuous Improvement: Identify equipment reliability risks and process inefficiencies; implement improvements such as steam trap surveys, condensate recovery optimization, water chemistry automation, VFD tuning, and predictive monitoring, including vibration, thermography, oil analysis, and electrical infrared. 

Required Skills and Abilities  

• Education: High School Diploma, associate degree or technical diploma in Mechanical/Electrical/Mechatronics/Industrial Maintenance or equivalent military/apprenticeship training; or related field a plus. 

• Experience: 6–10+ years in maintenance within GMP biopharma or cell therapy/ATMP manufacturing, including cleanroom facilities and regulated utilities. 

• GMP Knowledge: Strong command of cGMP, GDP, change control, deviation/CAPA, and validation/qualification principles, including for clean steam and utility systems. 

•  Systems: Proficiency with CMMS, EMS, and basic PLC/HMI interfaces; comfortable with digital workflows and electronic logbooks. 

•  Problem Solving: Demonstrated root cause analysis and reliability improvement results; data-driven decision making. 

•  Communication: Clear written and verbal communication for GMP records and cross-functional collaboration. 

Technical Competencies: 

• Cleanroom & GMP: Strong understanding of ISO cleanroom classification, contamination-control practices, aseptic environmental requirements, and maintenance execution in controlled environments. 

• Calibration/Qualification: Familiarity with GDP, CAPA, and Change Control. 

• Certifications: Equivalent safety training preferred; manufacturer training on production equipment, electrical controls, instrumentation, and GxP/cleanroom practices is advantageous. 

• Soft Skills: Strong communication, teamwork, and stakeholder management; ability to prioritize in a manufacturing environment, make decisions under time pressure, and document meticulously. 

• Physical & Work Requirements: Ability to lift 50 lbs, climb ladders, work in mechanical spaces and at heights, respond to after-hours calls/on-call rotation, and use PPE appropriate to labs/cleanrooms.