Engineer I

Amgen

Thousand Oaks, CA

Estimated pay: Est. $34–$49/hr (market estimate, not employer-stated)

Shift: Full time

Career Category Engineering Job Description Join Amgen’s Mission of Serving Patients At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do. Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year. Amgen is advancing a broad and deep pipeline of medicines to treat cancer, heart disease, inflammatory conditions, rare diseases, and obesity and obesity-related conditions. As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives. Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career. Engineer I What you will do Let’s do this. Let’s change the world. In this vital role you will support manufacturing activities associated with cGMP equipment and facilities at Amgen Thousand Oaks (ATO). The engineer works in partnership with the automation, maintenance, project management, corporate engineering, and manufacturing to develop and lead all aspects of the operation and reliability of equipment while driving safety and quality compliance. The engineer will support the department and capital projects and provide data to support business cases and long term strategy. The Engineer role will provide direct engineering technical support as follows: Model leadership behaviors and positive values to create a positive working environment. Be individually accountable for consistent equipment performance and reliability Be accountable for assigned results on key capital projects Suggest design modifications to address risks and design in quality and safety. Provide oversight for verification work developed by outsourced/contract verification staff. Act as a liaison between Engineering, Automation, Maintenance, Instrumentation, and Quality Assurance during project planning, execution, and closeout Ensure that validation protocols are executed and documented in accordance with cGMP good documentation and safety practices. Ensure safety during commissioning, validation, maintenance, and manufacturing activities Initiate and drive continuous improvement activities and projects to completion. Participate or lead, when required, multidisciplinary site teams, e.g. Multi-functional Team, Root Cause Analysis lead. Support Lean Transformation and Excellence in Operations process improvement by leading, supporting, and documenting improvement opportunities to reduce cost, improve safety/quality, or improve speed. Provide ad hoc technical support and guidance for manufacturing and maintenance Mentor and guidance to project teams and engineers using risk-based approaches Defend the equipment-specific calibration, maintenance, validation as required during regulatory inspections Participate in internal audits and assess in conjunction with quality assurance Assist in developing and maintaining business metric performance What we expect of you We are all different, yet we all use our unique contributions to serve patients. The professional we seek is a leader with these qualifications. Basic Qualifications: Master’s degree OR Bachelor’s degree and 2 years of engineering and/or manufacturing experience OR Associate’s degree and 6 years of engineering and/or manufacturing experience OR High school diploma / GED and 8 years of engineering and/or manufacturing experience Preferred Qualifications: Bachelor s degree in engineering or another science-related field 7 years of relevant work experience with 5 years’ experience in operations/manufacturing environment Direct experience with regulated environments (FDA, OSHA, EPA, etc.) Knowledge and experience with cGMP procedures and engineering practices on pharmaceutical/biotech production processes, clean utilities, facilities, instruments, and equipment Experience implementing risk-based verification on major GMP process equipment / automation projects, including validation protocol development and execution Experience with combination product / medical device quality systems verification Process equipment knowledge – basic principles of cell culture, fermentation, purification, filling Process automation knowledge – fundamental understanding of automation infrastructure Knowledge of Delta V, Rockwell, and Plant Information Systems is a plus Strong communication and technical writing skills Strengths in facilitation and collaboration / networking Experience in developing SOPs and delivering training Individual must be a standout colleague prep