Role Summary
The Plant Engineer II is responsible for supporting maintenance and operations at a GMP facility to support manufacturing activities in a cGMP environment to meet user needs and QA compliance requirements. The Plant Engineer will support the Facilities department with maintenance, operations, and projects, and will support the on-call facilities tech as needed to support 24/7 manufacturing operations. The hours for this position are Wednesday-Saturday 1:00 pm-11:30 pm. The hours during training (up to 4 month) will be Monday-Friday 8:30 am-5:00 pm.
Responsibilities
- Manages HVAC system maintenance and operations
- Manages control temperature rooms (Cold and Warm Rooms) maintenance and operation
- Supports maintenance and repair of clean utilities (Autoclaves, Water systems, Clean Steam, and Glass Washers)
- Supports the team by occasionally being a part of the On-Call Rotation.
- Facilities Subject Matter Expert (SME) for document review and capital projects
- Own change controls and drive to closure in a timely manner, ensure RAM (CMMS) data base modifications are properly completed for new equipment and changes to systems.
- Executes small facilities maintenance projects.
- Develops PM procedures.
- Verify system drawings are accurate.
- Responsible for critical spare parts inventory
- Ensures their work meets QA compliance requirements, that all tasks are completed on schedule, and problems are resolved in an efficient and effective manner.
- Develops specifications and procedures for the Maintenance operations.
- Responsible for special projects as directed by supervisor.
- Performs all other duties as assigned.
Qualifications
- 4-year degree college degree majoring in engineering or technical discipline and 2-5 yearsβ experience or equivalent facilities or construction experience.
- Previous experience in medical device, biotech, or R & D facilities preferred.
- This position requires excel organizational skills, ability to manage multiple tasks concurrently, and excellent verbal and written communication skills.
- cGMP knowledge required.
- Ability to work with other Facilities groups and other departments to problem solve issues. Strong collaboration abilities.
- Self-starter who can perform tasks with minimal supervision.
- Computer literate with Microsoft products such as Excel, Word, Power Point
- Problem solving skills.
- Ability to work cross functionally across all Organogenesis departments.
- Ability to support off hours work and on call technicians 24/7.
Education
- 4-year degree college degree majoring in engineering or technical discipline and 2-5 yearsβ experience or equivalent facilities or construction experience.
Additional Requirements
- Approximately 6 hours per day of standing.
- Ability to climb into and crawl through a low clearance mezzanine.
- Ability to climb a ladder to the roof.
- Occasionally around loud noises
- Occasionally in outdoor weather extremes of High Humidity during the summer and out in the snow in the winter around mechanical and utility equipment.