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Maintenance Technician Senior
2 months ago
Job Summary:
We are seeking a highly skilled Maintenance Technician Senior to join our team at BioPharma Consulting JAD Group. As a key member of our Facilities and Engineering Department, you will be responsible for overseeing the maintenance and repair of equipment and systems used in the biopharmaceutical industry.
Key Responsibilities:
- Maintain and repair all production mechanical equipment to ensure optimal performance and compliance with regulatory requirements.
- Support the maintenance, operation, and repair of all systems, subsystems, and equipment within the Amgen Fill / Finish facility.
- Collaborate with engineering and operations teams to design, install, test, operate, and maintain Fill Finish manufacturing and support equipment.
- Ensure all assigned equipment and associated subsystems are maintained in accordance with Federal, State, Local, and Amgen regulations, procedures, and policies.
- Maintain all assigned equipment areas in a constant state of inspection readiness.
- Identify training deficiencies and provide recommendations and training where applicable.
- Continuously evaluate and improve maintenance practices and documentation.
- Perform troubleshooting of electrical, pneumatic, and mechanical equipment.
- Complete preventive maintenance and assigned paperwork following all cGMP documentation guidelines.
- Coordinate contractors for repairs, modifications, and installations of equipment.
- Work directly with Manufacturing, Engineering, and Quality organizations on new system installations or modifications.
- Attend all required cGMP and Safety training.
- Maintain qualifications as assigned.
- Developing, writing, and completing various quality systems and safety documentation such as: Standard Operating Procedures (SOP), Change Control (CCMS), Non-Conformance (NC), Work Orders (WO), Job Plans (JP), Hazard Risk Assessments (HRA), Job Hazard Assessments (JHA), etc.
- Required to know, comprehend, and apply packaging configurations, as well as understand, follow and document batch records for the inspection and packaging process.
- Reconcile components and products, and calculate product exposure to room temperatures.
Requirements:
- Associate degree with 4 years of experience OR High school diploma / GED with 6 years of experience.
Shift:
- Night Shift (4 nights on, 3 nights off)
