We are seeking an innovative and highly motivated GMP Facilities Engineer who will contribute significantly to the success of service maintenance, repair, and support of the Cellares Bridgewater, NJ Facility and associated equipment.

This position's primary focus will be performing preventative maintenance, repairs, calibration, and troubleshooting of GMP process equipment and Cellares Utility and Facility equipment. It is a hands-on position 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 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
Manage parts, order, and coordinate with equipment vendors and area owners to schedule maintenance activities
Maintain tools and test equipment and ensure they are properly calibrated and in good 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.

See more open positions at Cellares

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