We are seeking an innovative and highly motivated Service Engineer who will contribute significantly to the success of service maintenance, repair, and support for Cellares’ equipment.
The primary focus of this position will be to perform preventive maintenance, repairs, calibration, and troubleshooting of GMP Cellares process equipment. This is a hands-on position and local to the South San Francisco, CA facility.
Candidates should enjoy working in a fast-paced, mission-driven environment and be prepared to tackle a wide range of challenges as the company expands. This role will primarily be in our South San Francisco, California, facility, with up to 20% travel to our Bridgewater, New Jersey, and other Cellares locations.
Responsibilities
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.
Execute preventive maintenance activities to ensure optimal functionality of manufacturing equipment
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 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
Participate in an after-hours on-call rotation to support GMP facility operations is required and managed through PagerDuty
Experience drafting and maintaining Standard Operating Procedures (SOPs) and Work Instructions (WIs)
Requirements
Bachelor’s 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
Experience as a technical/service lead on a multi-subsystem installation/qualification
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 a full-time, 40-hour work week, including swing shifts, weekends, and holidays, as required to support business needs
Attendance at the plant site is considered an essential function
Detail-oriented with a commitment to maintaining high-quality standards
Must be able to lift and carry up to 50 lbs
Excellent verbal, written, organizational, presentation, and interpersonal skills
Self-Awareness, integrity, authenticity, and a growth mindset
Nice to Haves
Experience with PLC automated control systems
Experience with 6-axis robots
Experience working safely with high voltage systems (208V)
Cellares total compensation package contains competitive base salaries, highly subsidized Medical, Dental, and Vision Plans, 401(k) Matching, Free EV Charging, Onsite lunches, and Stock options. All displayed pay ranges are approximate, negotiable, and location dependent.
Additional Information
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.
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