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Maintenance Technician Senior
2 months ago
Join the team at BioPharma Consulting JAD Group as a Maintenance Technician Senior. In this role, you will be responsible for overseeing the maintenance and repair of equipment and systems used in the biopharmaceutical industry. You will work closely with the Facilities & Engineering Department to ensure equipment reliability and compliance with regulatory requirements. This is a senior-level position that requires extensive experience and knowledge in maintenance practices and procedures related to biopharmaceutical manufacturing.
Responsibilities:
- Maintain and repair all production mechanical equipment.
- Support the maintenance, operation, and repair of all systems, subsystems, and equipment within the Amgen Fill / Finish facility.
- Provide support to engineering and operations in the design, installation, testing, operation, and maintenance of 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.
Skills:
- Strong documentation and attention to detail skills.
- Thorough working knowledge of pharmaceutical filling, freeze drying, and packaging equipment operation, maintenance, and repair.
- Full working knowledge of pumps, valves, mechanical seals, motors, and proper lubrication.
- Precision machinery experience highly preferred.
- Electro-mechanics/electrical background.
- Troubleshooting experience (electrical or mechanical).
- GMP background and cleanroom experience.
- Ability to create, read, interpret, and revise engineering documents.
- Strong writing skills for preparing technical reports and documentation.
- Familiarity with machine shop equipment including CNC machine and lathe is a plus.
- Ability to work safely with hazardous chemicals, high and low temperature liquids, high pressure liquids and gases steam, varying electrical voltages, and moving machinery.
- Ability to read and understand P&IDs, work from SOPs, and use basic computer skills.
- Knowledge of and ability to use Computerized Maintenance Management Systems.
- Detail-oriented and organized with good record-keeping practices.
- Effective communication skills and ability to work with minimum or no supervision.
- Capable of multi-tasking and working overtime or temporarily modifying shift schedule as needed.
- Ability to lift up to 50 pounds, climb ladders, and work at elevations up to 15 feet.
Requirements
Qualifications:
- 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)
