Facilities Maintenance Engineer

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

This is Cellares

Cellares is the first Integrated Development and Manufacturing Organization (IDMO) and takes an Industry 4.0 approach to mass manufacturing the living drugs of the 21st century. The company is both developing and operating integrated technologies for cell therapy manufacturing to accelerate access to life-saving cell therapies. The company’s Cell Shuttle integrates all the technologies required for the entire manufacturing process in a flexible and high-throughput platform that delivers true walk-away, end-to-end automation. Cell Shuttles will be deployed in Cellares’ Smart Factories around the world to meet total patient demand for cell therapies at global scale. Partnering with Cellares enables academics, biotechs, and pharma companies to accelerate drug development and scale out manufacturing, lower process failure rates, lower manufacturing costs, and meet global patient demand. The company is headquartered in South San Francisco, California with its commercial-scale IDMO Smart Factory in Bridgewater, New Jersey. The company is backed by world-class investors and has raised over $355 million in financing.

Leveling will be based on overall experience, education, and demonstration of knowledge throughout the interview process.