Plant Engineer II/III

Role Summary

The Plant Engineer II/III supports maintenance and operations at a GMP facility to support manufacturing activities in a cGMP environment, ensuring QA compliance. Responsibilities include supporting Facilities with maintenance, operations, and projects, and providing on-call support for 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 work meets QA compliance, tasks completed on schedule, and problems resolved efficiently
• Develops specifications and procedures for 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’ experience or equivalent facilities/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 collaborate with Facilities groups and other departments
• Self-starter with minimal supervision
• Proficient in Microsoft Excel, Word, PowerPoint
• Problem solving skills
• Ability to work cross-functionally across all departments
• Ability to support off-hours work and on-call technicians 24/7

Skills

• Facilities management
• Project coordination
• Change control and RAM/CMMS proficiency
• GMP/compliance interpretation
• Technical documentation and procedure development
• Cross-functional collaboration

Education

• 4-year degree in engineering or technical discipline (or equivalent)

Additional Requirements

• Physical demands include standing several hours per day, climbing into low-clearance mezzanines, and climbing ladders to the roof
• Occasional exposure to loud noises and outdoor weather extremes