Factory Service Engineer
Listed on 2025-12-20
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Engineering
Manufacturing Engineer, Quality Engineering, Operations Engineer -
Manufacturing / Production
Manufacturing Engineer, Quality Engineering, Operations Engineer
Factory Service Engineer
Cellares – Bridgewater, New Jersey – 3rd Shift full‑time
We are seeking an innovative and highly motivated Service Engineer to contribute significantly to the success of service maintenance, repair, and support for Cellares’ equipment in a GMP cell therapy manufacturing environment.
Responsibilities- Perform installations, routine maintenance, and troubleshooting of Cellares and other process equipment in a GMP cell therapy facility.
- Collaborate with cross‑functional teams to ensure compliance with GMP standards and regulations.
- Execute 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.
- Maintain accurate documentation of all maintenance activities and equipment logs in a computerized system (CMMS).
- Manage parts ordering and coordinate with equipment and area owners to schedule maintenance activities.
- Collaborate with manufacturing and quality control teams to address technical issues and optimize processes.
- Support quality change controls and CAPA investigations.
- Participate in training programs to enhance technical skills and knowledge.
- Participate in an after‑hours on‑call rotation to support GMP facility operations.
- Draft and maintain 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 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.
- 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.
- Experience with PLC automated control systems.
- Experience with 6‑axis robots.
- Experience working safely with high voltage systems (208V).
- Experience with Blue Mountain CMM.
$90,000 – $210,000 a year.
Cellares is the first integrated development and manufacturing organization (IDMO) focused on mass manufacturing of living drugs. The company combines advanced cell therapy manufacturing technologies with industry 4.0 automation to deliver end‑to‑end solutions globally. Cellares is backed by world‑class investors and has raised over $355 million in financing.
All displayed pay ranges are approximate, negotiable, and location dependent.
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