GMP Factory Service Engineer
Bridgewater, NJ, USA
Posted on Friday, February 9, 2024
We are seeking an innovative and highly motivated Factory Maintenance Engineer who will contribute significantly to the success of service maintenance, repair, and supporting Cellares with their equipment.
The primary focus of this position will be to perform preventative maintenance, repairs, calibration, and troubleshooting of GMP Cellares process equipment. This is a hands-on position and local to the Bridgewater, NJ facility.
Candidates should enjoy working in a fast-paced, mission-driven environment, and be prepared to tackle a broad selection of challenges as the company grows.
- Perform installations, routine maintenance and troubleshooting of Cellares and other process equipment within a Good Manufacturing Practice (GMP) environment in a cell therapy manufacturing facility
- 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 the installation and qualification of 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)
- Manage parts ordering and coordinate with equipment and area owners to schedule maintenance activities
- Maintain tools and test equipment and ensuring 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
- Associate degree or equivalent in engineering or a related field
- 5+ years’ 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
- Must be able to work 40 hours a week, which may include weekends, holidays, etc.
- Attendance in the plant site is considered an essential function
- 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.