This position will provide technical support to facilities maintenance and ICE technicians, investigating and correcting equipment deficiencies and working to implement process improvements. This role is key to ensuring that both facilities and manufacturing departments meets their goals and objectives. The successful candidate must be able to provide technical leadership and guidance to others and work effectively in a team environment.
The principal responsibilities for this role are:
- Will function as the system owner for various utility systems and equipment.
- Provide technical oversight and leadership for key Facilities department business processes such as mechanical integrity program, pest control program, USP water system maintenance, CMMS equipment database, etc.
- Interact on a daily basis with facilities and manufacturing department personnel to identify and correct deficiencies in equipment or facilitate PM program execution and improvements.
- Author investigations and develop and implement CAPA tasks to prevent recurrence of equipment or procedural failures.
- Implement equipment improvements through the change control process. Must be able to plan and execute small projects from inception, design, installation, commissioning and startup.
- Administers "operational" cGMP requirements that involve contract resources.
- Primary author, developer, and trainer for assigned Facilities' owned SOP's.
- Technical resource and trainer to both the facilities / maintenance group as well as group resource to the plant.
- Utilize historical data to identify and correct problems, verify proper equipment/system operations.
- Identify and implement energy savings programs to enhance environmental sustainability.
- Participate in regulatory and customer audits and resulting CAPA tasks through implementation.
BS/MS in Mechanical, Electrical or Chemical Engineering with prior experience in chemical processing or API environment preferred with 5 plus years of experience.
The successful candidate should be knowledgeable about basic principles of operation for process and utilities equipment such as pumps, piping and valves, heat exchangers, agitators and mixing equipment, HVAC systems and controls, etc. Practical experience in a highly regulated industry is mandatory for success in the Facilities Engineer role. Experience working in a GMP environment, with a working knowledge of change control and investigations is highly desired. Additionally:
Knowledge of Computerized Maintenance Management Systems (CMMS), Preventive Maintenance, Predictive Maintenance (PdM), Proactive Maintenance (PaM), HVAC, process controls, SCADA, process operations / unit operations, reliability technologies and practice, Failure Mode and Effects Analysis (FMEA), Reliability Center Maintenance (RCM), Root Cause Failure Analysis (RCFA), etc. and experience or exposure to other process / field disciplines