Simi Valley, CA, 93099, USA
18 hours ago
GMP Maintenance Technician
**GMP Maintenance Technician** Manufacturing & Utilities Simi Valley, CA, US + Added - 03/01/2025 Apply for Job _Our client, a renowned leader in the field of biotechnology, is revolutionizing the use of living cells to create groundbreaking biologic medicines. We are excited to announce a fantastic opportunity to join the team as a_ **_Maintenance Technician Senior_** _!_ **Location:** Thousand Oaks, CA **Shift:** *Multiple positions open* **Pay:** Open, depending on relevant experience **Key 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. + Assist in the design, installation, testing, operation, and maintenance of Fill/Finish manufacturing and support equipment. + Ensure all assigned equipment and associated subsystems comply with Federal, State, Local, and Amgen regulations, procedures, and policies. + Keep all assigned equipment areas in a constant state of inspection readiness. + Identify training gaps and provide recommendations and training where necessary. + Continuously assess and improve maintenance practices and documentation. + Troubleshoot electrical, pneumatic, and mechanical equipment. + Complete preventive maintenance and required paperwork in compliance with cGMP documentation standards. + Coordinate contractors for repairs, modifications, and installations of equipment. + Collaborate with Manufacturing, Engineering, and Quality teams on new system installations or modifications. + Attend all required cGMP and safety training. + Maintain required qualifications as assigned. **Qualifications/Requirements:** + Thorough working knowledge of pharmaceutical packaging equipment operations, maintenance, and repair. + Expertise in pumps, valves, mechanical seals, motors, and proper lubrication techniques. + Strong documentation and attention to detail. + Comprehensive knowledge of cGMP and Predictive Maintenance techniques. + Ability to create, read, interpret, and revise engineering documents. + Excellent writing skills for preparing technical reports and documentation. + Ability to collaborate effectively with customers and become a resource to them. + Skilled in identifying and implementing process improvements. + Familiarity with machine shop equipment, including CNC machines and lathes, is a plus. + Ability to safely work with hazardous chemicals, high/low temperature liquids, high-pressure liquids/gasses, steam, varying electrical voltages, and moving machinery. + Proficient in reading and understanding P&IDs, working from SOPs, and using basic computer skills. + Experience with Computerized Maintenance Management Systems (CMMS). + Detail-oriented with strong organizational and record-keeping practices. + Effective communication skills and the ability to work with minimal supervision. + Capable of multi-tasking and working overtime or modifying shift schedules as needed. + Ability to lift up to 50 pounds, climb ladders, and work at heights up to 15 feet. INDBH \#LI-DNP We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.
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