Plant Engineer II

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 may support the on-call facilities tech to support 24/7 manufacturing operations.

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 in engineering or technical discipline and 2-5 years‚Äô experience or equivalent facilities or construction experience
• Previous experience in medical device, biotech, or R&D facilities preferred
• Excellent organizational, verbal, and written communication skills
• cGMP knowledge required
• Ability to work with other Facilities groups and departments to problem solve; strong collaboration abilities
• Self-starter who can perform tasks with minimal supervision
• Computer literate with Microsoft Excel, Word, PowerPoint
• Problem-solving skills
• Ability to work cross-functionally across all Organogenesis departments
• Ability to support off-hours work and on-call technicians 24/7

Skills

• Facilities management
• Change control and CMMS
• Project management
• Documentation and QA compliance
• Systems knowledge: HVAC, clean utilities, autoclaves, water systems, clean steam
• Cross-functional collaboration

Education

• 4-year degree in engineering or technical discipline

Additional Requirements

• Physical demands: 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
• Environmental conditions: occasionally loud noises; occasional exposure to outdoor weather extremes