Career Category Maintenance Job Description Are you looking for a challenging new opportunity to test and growth your process control and instrumentation skills? We have an immediate need for a top-tier Sr Instrument Technician to join AML6-Drug Substance Equipment Maintenance team. The position is aligned to a non-standard work scheduled. This is an outstanding opportunity to tackle on a variety of challenges and responsibilities around our state-of-the-art Mammalian Cell Culture and Purification facility at Amgen Manufacturing Limited in Juncos, Puerto Rico. The role Under the supervision of the shift Facilities Maintenance Manager, calibrates, repairs, installs, troubleshoots, loop checks instruments and process control systems used in manufacturing, utility plants and analytical laboratories. You will be also responsible to prepare and maintain an array of records; make written reports of work activities; and perform related work as require to assure minimal impact to production while complying with cGMP and Amgen regulations All work to be completed in a safe and timely manner in accordance to planning and pre-defined schedules with minimal impact to production while aligning with Good Manufacturing Practices (GMPs), standard operating procedures (SOP) and Amgen policies and regulations. We seek a hands-on problem solver, standout colleague, and someone comfortable within an innovative, fast paced environment. You will also contribute with the team by your assistance in maintaining an up-to-date working spare parts inventory system for the equipment/ systems the team is responsible for. You will provide detailed training for the team in order to develop the teams knowledge in the instrumentation field and other areas of the plant. Plus, your deep understanding of the big picture will be vital as you help to develop deviation documents, and craft even-more efficient methods and processes around the facility. The department The AML-6 Facility is the home of best-in-class, multi-product Drug Substance Manufacturing Operations. The facility highlights the combination of groundbreaking manufacturing sciences and process technology, advanced equipment engineering and automation, and a high-performance culture integrating cross-functional teams from across the site with the goal of achieving being the best mammalian drug substance manufacturing facility in the world. Specific responsibilities included but not are limited to: - Perform advanced calibrations of instruments on process and utility equipment. - Assist the team with maintaining an up-to-date working spare parts inventory system for the equipment/ systems the team is responsible for. - Ensure that calibration paperwork, instrument files and work order documentation is completed with accurate information. - Assist in the evaluation of the current calibration cycles and make appropriate changes to optimize the calibration program. - Provide detailed training for the team in order to develop the teams knowledge in the instrumentation field and other areas of the plant. - Complete assigned activities following the most highest standards in safety. - Develop, revise, and review SOPs for work related areas. - Install, configure repair, and start-up microprocessor based instruments and controllers. - Troubleshoot and repair hardware problems for computer based process control systems. - All work must be completed in accordance with CFRs, cGMPs, SOPs, and Amgen policies. - Perform regular certification of equipment to verify conformance to industry standards and Amgen procedures . - Maintain an up to date cGMP training book. - Plan and schedule own work activities and coordinate work done by contractors with operations staff to minimize impact to production activities - Interpret and update loop sheets, electrical schematics, P & ID's, I/O wiring, and panel drawings. - Assist in start-up of new equipment to ensure it meets all instrumentation design specifications. - Assist with the development and execution of validation documents for instrumentation equipment. Basic Qualifications Associates degree & 4 years of Maintenance experience Or High school diploma & 6 years of Maintenance experience Beyond that, the preferred qualifications are: - A skilled crafts-person knowledgeable of pneumatic, mechanical, and electronic instrumentation. - Maintenance experience in a GMP regulated industry - Basic understanding of process control loops and process control systems, including those that are computer based. - Has received training or hands on experience in such specialized subjects as theory of control, analog and/or digital electronics, microprocessors and/or computers, and the operation and maintenance of particular lines of field instrumentation. - Ability to effectively communicate ideas through verbal and writtenform - Advanced computer skills - Ability to interact constructively with peers/teams - Ability to collaborate and coordinate with higher level outside resources The benefits Our broad approach is one of the reasons why we are regularly recognized as a Best Place To Work. We offer a superior benefits package that includes health insurance benefits, performance bonus an award-winning retirement plan. And between the paid time off, and wellness program and on-site child care and fitness facilities you will find us focused on your well-being too. Our culture is what makes Amgen a special place to work. We have a powerful shared purpose around our mission to serve patients. We respect one another, recognize contributions, and have embedded collaboration, trust, empowerment and inclusion in all that we do. We equip all our staff members to live well-rounded, healthy lives. Most recently, Amgen added benefits for transgender employees and continues to pride itself on industry-leading, family-friendly offerings for families of all compositions. Amgen focuses on areas of high unmet medical need and uses its expertise to strive for solutions that improve health outcomes and dramatically improve peoples lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the worlds leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential. Join Us If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen. Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses. As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients. Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status. .
