Lead GMP Maintenance Specialist (2nd Shift)

Wave Life Sciences.
Lexington, MA, US
Full-time

Responsibilities

May include some or all of the following :

  • Trains New Facilities personnel when necessary
  • Coordinates maintenance and work activities with manufacturing, quality control, and process development groups.
  • Assists in reviewing work orders for accuracy and content.
  • 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 wastewater 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 have or obtain Level 2 (or higher) wastewater operator’s license.

Skills / Pre-requisites :

  • Ability to plan, coordinate, perform, and document work with minimal to no 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 available for 24 hour support of manufacturing operations.
  • 30+ days ago
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