46 минут назад
Facilities Maintenance Engineer (Cell Therapy Manufacturing)
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Facilities Maintenance Engineer (Cell Therapy Manufacturing): Maintaining, repairing, calibrating, and troubleshooting GMP process, utility, and facility equipment at a cell therapy manufacturing facility with an accent on preventive maintenance, validation support, and regulatory compliance. Focus on responding to equipment failures, qualifying new equipment, managing CMMS documentation, and supporting quality change controls and CAPA investigations.
Location: Bridgewater, New Jersey, United States; on-site, swing shift
Company
operates a cell therapy manufacturing facility with GMP process, utility, and facility equipment.
What you will do
- Perform preventive maintenance, repairs, calibration, troubleshooting, and alarm response for GMP manufacturing and facility equipment.
- Support equipment validation, qualification, installation, and commissioning in accordance with GMP requirements.
- Respond to equipment failures, implement corrective actions, minimize downtime, and provide on-call support as required.
- Maintain accurate maintenance records, equipment logs, tools, and test equipment in the CMMS.
- Coordinate maintenance activities with equipment vendors, area owners, manufacturing, facilities, and quality control teams.
- Support quality change controls, CAPA investigations, and continuous improvement initiatives.
Requirements
- Associate degree or equivalent in engineering or a related field, plus five or more years of experience in a GMP manufacturing environment.
- Strong understanding of GMP regulations and quality standards, preferably in cell therapy or biopharmaceutical manufacturing.
- Proficiency in troubleshooting and repairing complex manufacturing equipment, including familiarity with technical documents and engineering drawings.
- Experience with building maintenance systems and environmental monitoring systems.
- Strong organizational, documentation, communication, and collaboration skills.
- Ability to lift and carry up to 50 lbs.
Nice to have
- Experience with HVAC, RTUs, split systems, LP boilers, air compressors and dryers, process gas distribution, and process laboratory equipment.
Culture & Benefits
- Hands-on work in a fast-paced, mission-driven environment.
- Participation in technical training programs and continuous improvement initiatives.
- Cross-functional collaboration with manufacturing, facilities, quality control, vendors, and area owners.
- Swing-shift schedule with on-call support as required.
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