Position Summary
Swing Shift
We are seeking an innovative and highly motivated Facilities Maintenance Engineer who will contribute significantly to maintenance, repair, and support for equipment at the Cellares Bridgewater, NJ facility.
The primary focus of this position will be to perform preventive maintenance, repairs, calibration, and troubleshooting of GMP process equipment, along with Cellares Utility and Facility equipment. This is a hands-on position that is local to the Bridgewater, NJ facility.
Candidates should enjoy working in a fast-paced, mission-driven environment and be prepared to tackle challenges as the company grows.
Responsibilities
Perform routine maintenance and troubleshooting of Cellares and other process equipment in a cell therapy manufacturing facility in a Good Manufacturing Practice (GMP) environment
Collaborate with cross-functional teams to ensure compliance with GMP standards and regulations
Perform equipment calibrations and support validation testing to meet quality and regulatory requirements
Respond promptly to equipment failures and implement corrective actions to minimize downtime. Provide on-call support as required
Execute preventative maintenance activities to ensure optimal functionality of manufacturing equipment
Support installing and qualifying new equipment, ensuring adherence to GMP guidelines
Support the facilities team in providing maintenance and repair in the GMP environment as needed
Maintain accurate documentation of all maintenance activities and equipment logs in a Computerized Maintenance Management System (CMMS)
Execute alarm response and proficiency in Building Maintenance Systems and Environmental Monitoring Systems
Order, coordinate, and schedule maintenance activities with equipment vendors and area owners
Maintain tools and test equipment to ensure they are calibrated and in safe working condition
Collaborate with manufacturing and quality control teams to address technical issues and optimize processes.
Support Quality Change Controls and CAPA investigations
Stay updated on industry trends and advancements to contribute to continuous improvement initiatives
Participate in training programs to enhance technical skills and knowledge
Additional Equipment Experience:
Experience with HVAC, RTUs, Split Systems, LP Boilers, Air Compressors/dryers, Process Gas Distribution, Process Lab equipment (BSCs, Incubators, FZRs, REFs, Cryo Storage, Centrifuges, Pumps, Vacuum Skids, and backflow preventers is a plus
Requirements
Associate degree or equivalent in engineering or a related field with five plus years of experience in a GMP manufacturing environment, preferably in cell therapy or biopharmaceuticals
Strong understanding of GMP regulations and quality standards
Proficient in troubleshooting and repairing complex manufacturing equipment
Ability to read and understand technical documents and engineering drawings
Excellent organizational and documentation skills
Ability to work collaboratively in a team-oriented environment
Effective communication skills to interact with diverse stakeholders
Detail-oriented with a commitment to maintaining high-quality standards
Ability to lift and carry up to 50 lbs
