Facility / Utility Engineer
The Utilities/Facilities Engineer is responsible to be the system owner for some new utility systems. The engineer’s main responsibilities is to ensure all systems are mechanically complete, commission and hand them over to the site team.
- Responsible for projects, vendor inquires and troubleshooting of process and utilities systems.
- Participate on capital project teams through all phases of projects; these phases will include conceptual design, detailed design, equipment procurement, construction, installation, start up, commissioning, validation, and qualification.
- Responsible for initiation and completion of deviations, CAPAs, and change controls for process and utility systems
- Provide support to manufacturing and maintenance where required.
- Provide on-call support during project and shutdown activities, as required.
- Ensure completion of preventative maintenance and capital improvement activities in accordance with shut down plan.
- Ensure that new equipment is included in the plant maintenance and calibration program.
- Plans and manages maintenance shutdown activities.
- Oversees process and utility system upgrades
- Performs investigations relating to equipment malfunctions.
- Other duties as required.
- 5 years relevant experience in a cGMP commercial manufacturing environment
- Experience in troubleshooting and providing technical support for cGMP manufacturing, equipment, utilities, and HVAC systems in a biological or aseptic processing environment
- Experience with sanitary design of piping and manufacturing equipment
- Ability to read and understand sophisticated architectural, equipment and system drawings.
- Knowledge of GMP utility systems (i.e. CIP, SIP, WFI, clean steam, pharmaceutical gas systems).
- Experience in working with equipment manufacturers and developing preventative maintenance procedures for cGMP manufacturing equipment
- BS in chemical or mechanical engineering plus 5-8 years relevant experience in a cGMP commercial manufacturing environment or MS in chemical or mechanical engineering plus 2-5 years relevant experience in a cGMP commercial manufacturing environment.