Factory Service Engineer

BridgewaterFull Timemid

Service EngineerSkilled Trades & Field Services

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Overview

CELLARES, Bridgewater,

Technical Tools

Service EngineerSkilled Trades & Field Services

CELLARES, Bridgewater, New Jersey Facility

FULL-TIME 3rd Shift

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.

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)

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

Preferred Experience

Experience with PLC automated control systems

Experience with 6-axis robots

Experience working safely with high voltage systems (208V)

Experience with Blue Mountain CMM