Summary
The Equipment Specialist supports aseptic fill-finish manufacturing operations by ensuring the reliability and performance of production and facility equipment. This role serves as a frontline responder for equipment issues on the manufacturing floor, providing quick assessment, troubleshooting, and resolution to minimize downtime. The position includes participation in an on-call rotation to support operations.
Responsibilities
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Maintain, diagnose, and repair critical manufacturing and facility systems, including sterilization units, filling systems, washers, ovens, lyophilization equipment, and environmental control systems.
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Plan, coordinate, and execute preventive maintenance activities and work order management.
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Serve as a technical lead for equipment upkeep, reliability, and performance optimization.
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Lead and support planned shutdowns and major maintenance events.
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Perform operational readiness checks and equipment verification prior to production activities.
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Support automated production system interventions and recovery efforts.
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Prepare and contribute to GMP documentation, including deviations, investigations, CAPA activities, and change management processes.
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Provide technical support for site-based projects and continuous improvement initiatives.
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Participate in on-call production support to ensure uninterrupted manufacturing operations.
Qualifications
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Strong technical documentation and written communication skills.
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Proficient in digital maintenance systems and adherence to cGDP standards.
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Advanced troubleshooting capabilities for integrated mechanical, electrical, and control systems.
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Hands-on technical expertise across mechanical, electrical, and pneumatic disciplines in regulated manufacturing environments.
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Qualified for cleanroom operations and aseptic gowning procedures.
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High school diploma required; advanced technical or vocational training preferred.
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