Factory Service Engineer

Cellares • Bridgewater, NJ

12d • $90,000 - $210,000 • Onsite

About The Position

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, retrofits, upgrades, repairs, calibration, and troubleshooting of GMP Cellares process equipment. This is a hands-on position, and on-site at 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. This role will primarily be in our Bridgewater, New Jersey, facility, with up to 10% travel to our South San Francisco, California, facility and other Cellares locations.

Requirements

• Bachelor’s degree or equivalent in engineering or a related field
• 3+ years’ experience in a GMP manufacturing environment, preferably in cell therapy or biopharmaceuticals
• Basic 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 workweek, including weekends and holidays, as required to support business needs (Training will be performed during the day shift)
• 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)
• Experience with Blue Mountain CMM

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 End of Line testing, 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 system 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
• Participating 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)

Benefits

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 51-100 employees