**Maintenance/Facilities Engineer** Manufacturing & Utilities Thousand Oaks, CA, US Pay Rate Low: 30 | Pay Rate High: 45 + Added - 14/11/2024 Apply for Job **We are seeking an experienced** **Maintenance/Facilities Engineer** **to join our client, a leader in the pharmaceutical industry. The ideal candidate will have at least 10 years of experience in maintaining and repairing process or utility equipment, preferably within a GMP-regulated pharmaceutical environment. This role demands strong technical skills in electrical, mechanical, and electromechanical systems, with a solid understanding of HVAC systems being a bonus. The candidate must be self-sufficient, able to work independently, and manage rotating on-call duties, especially during after-hours shifts.** **Located in Thousand Oaks, California** **Pay:** **$30-45/hour** **Key Responsibilities:** + **Equipment Maintenance & Repair:** Perform preventive maintenance, troubleshooting, and repair of all production mechanical equipment, ensuring continued operation of Fill/Finish manufacturing systems. + **System Support:** Support maintenance, operation, and repair of all systems, subsystems, and equipment within the Amgen Fill/Finish facility. + **Project Support:** Assist engineering and operations teams with the design, installation, testing, and commissioning of new systems and equipment. + **Regulatory Compliance:** Ensure that all assigned equipment and subsystems meet Federal, State, Local, and Amgen regulatory requirements, as well as internal policies and procedures. + **Inspection Readiness:** Maintain all equipment areas in a constant state of inspection readiness, ensuring full compliance with GMP standards. + **Training & Development:** Identify training deficiencies and provide recommendations or on-the-job training where applicable to staff. + **Continuous Improvement:** Evaluate and enhance maintenance practices and associated documentation to improve efficiency and compliance. + **Troubleshooting:** Diagnose and resolve electrical, pneumatic, and mechanical issues in a timely and effective manner. + **Documentation:** Complete preventive maintenance tasks and maintain accurate, compliant documentation in accordance with cGMP standards. + **Contractor Coordination:** Coordinate external contractors for repairs, modifications, and installations of equipment and systems. + **Collaboration:** Work closely with Manufacturing, Engineering, and Quality teams during system installations, modifications, and troubleshooting. + **Safety & Compliance:** Attend all required cGMP, Safety, and other training as needed to maintain up-to-date qualifications. **Qualifications / Requirements:** + **Experience:** Minimum of 10 years of experience working with process or utility equipment in a regulated environment, ideally within the pharmaceutical, biotech, or other GMP-compliant industries. + **Technical Expertise:** In-depth knowledge of pharmaceutical packaging equipment, pumps, valves, motors, mechanical seals, and lubrication practices. + **Systems Knowledge:** Strong understanding of electrical, pneumatic, and mechanical systems. HVAC system knowledge is a plus. + **Documentation & Compliance:** Expertise in creating, reading, and interpreting engineering documents and ensuring adherence to cGMP standards. + **Predictive Maintenance:** Proficient in predictive maintenance techniques and philosophies. + **Maintenance Systems:** Familiarity with Computerized Maintenance Management Systems (CMMS) and work order systems. + **Machinery & Tools:** Experience with machine shop equipment, including CNC machines and lathes, is a plus. + **Safety Awareness:** Ability to work safely with hazardous chemicals, high- and low-temperature liquids, high-pressure systems, steam, electricity, and moving machinery. + **Skills:** Strong attention to detail, excellent communication skills, and the ability to work independently with minimal supervision. + **Physical Demands:** Must be able to lift up to 50 pounds, climb ladders, and work at heights up to 15 feet. + **Flexibility:** Willingness to work overtime, modify shift schedules, and participate in rotating on-call duties as needed. + **GMP Knowledge:** Familiarity with cGMP regulations and best practices; pharmaceutical industry experience is preferred, but candidates from related fields with an openness to learning GMP standards will be considered. \#INDBH 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.