The Maintenance Specialist plays a key role supporting commissioning, startup, and operations of WAVE’s new GMP clinical manufacturing facility in Lexington MA. This role will report to the site facilities manager, and will involve maintenance of utility, process, and monitoring equipment, as well as utility / facility operations support. The Maintenance Specialist will have a broad set of responsibilities across multiple trades.
May include some or all of the following:
Performs scheduled and emergency maintenance on critical process equipment, utility systems, HVAC systems, and facilities. Ensures quality of work and thoroughly documents all maintenance activities.
Participate and or leads the creation of SOPs, change controls, CAPAs, deviations, work instructions and evaluation of environmental monitoring excursion investigations.
Monitors Building Management System (BMS) and Critical Monitoring System (CMS), and documents / responds to alarms and event in accordance with cGMP guidance.
Providing supervision of work performed by maintenance service providers and contractors, ensuring work adheres to / aligns with WAVE Procedures. Responsible for quality and efficiency of work.
Provides routine facilities operational support, taking plant and utility readings, changing gas cylinders, and installing / changing out raw material drums.
Coordinates maintenance and work activities with manufacturing, quality control, and process development groups.
Monitors waste water system in accordance with MWRA / MA DEP requirements.
Implements small projects
Education / Experience:
High school diploma or equivalent. 7 - 9 years of relevant working experience in a comparable position (similar type of work, similar group dynamics)
Proven experience operating and maintaining industrial (bio-pharmaceutical, petrochemical, specialty chemical, etc.) production equipment and facilities
Experience troubleshooting pneumatic, electrical, hydraulic, and HVAC systems
Experience with control systems, PLC’s and BMS system operation.
Individual must have, or will be required to obtain Level 2 (or higher) wastewater operator’s license.
Skills / Pre-requisites:
Ability to plan, coordinate, perform, and document work with minimal supervision
Strong oral and written communication skills
Positive attitude, service oriented, and willingness / ability to perform maintenance on all equipment, systems, and facilities
Demonstrated analytical and problem solving skills
Must be able to perform under pressure, providing emergency troubleshooting and repair on critical process and utility systems.
Able to lift 40 pounds
Able to access crawl spaces and use ladders to access equipment.
Incumbent will be required to carry a cellular phone and be on call to support manufacturing operations