Process Engineer - CIP/ SIP/ Autoclave

Amgen

Holly Springs, NC

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. 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. Be part of Amgen s newest and most advanced drug substance manufacturing plant. When completed, the Amgen FleX batch facility will combine the latest in disposable technologies with traditional stainless steel equipment to allow for maximum flexibility in operations The FleX Batch facility will not only feature the best in-class drug substance manufacturing technologies with embedded industry 4.0 capabilities, but it will also integrate sustainability innovations to reduce carbon and waste, as part of Amgen s plan to be a carbon-neutral company by 2027. Process Engineer - CIP/ SIP/ Autoclave What you will do: In this vital role you will be joining the Facilities Engineering (F E) group to partner closely with the corporate engineering team to design, build, commission, and qualify new equipment and systems needed for drug substance production as well as developing domain expertise to support operations upon start-up. Site design, construction, start-up, and operational readiness: Support the commissioning and qualification of manufacturing systems in alignment with GMP requirements and interact with regulatory inspectors. Demonstrate technical expertise and provide lifecycle support for CIP skid systems, SIP circuits, autoclaves, transfer panels, process tanks, valves, instrumentation, and associated automation platforms. The role will support commissioning, qualification, startup readiness, routine manufacturing operations, troubleshooting, and continuous improvement initiatives with a focus on CIP, SIP and autoclave systems. Ensure systems are installed and operate safely and comply with pertinent environmental health/safety practice, rules and regulations. Interact with regulatory inspectors as a manufacturing systems owner to communicate and demonstrate appropriate regulatory compliance of operating systems. Assist with new product/technology introductions by performing engineering assessments, implementing equipment modifications, and supporting engineering runs. Site Operations: Provide system support for biopharmaceutical process equipment – specifically CIP/SIP and/or autoclave systems. Assist in identifying and implementing engineering-based improvements or upgrades to equipment or facility systems. Experience with CIP circuit design/validation and SIP Support the development of business cases for improvements, identification of design requirements, and translation of these requirements into process equipment/system design, specifications, and supporting the construction, startup, and validation of improvements. Develop equipment maintenance programs, ensure the availability of spare parts, and coordinate maintenance activities to ensure systems are in proper working order. What we expect of you We are all different, yet we all use our unique contributions to serve patients. The engineering professional we seek enjoys challenges and is motivated to help serve patients with these qualifications. Basic Qualifications: Master’s degree OR Bachelor’s degree and 2 years of Engineering experience OR Associate’s degree and 6 years of Engineering experience OR High school diploma / GED and 8 years of Engineering experience Preferred Qualifications: Bachelor’ s degree in Chemical or Mechanical Engineering or similar engineer discipline. 3 years of relevant work experience with 2 years experience in Biopharmaceutical operations/manufacturing environment Direct knowledge of design and troubleshooting with GMP Biopharmaceutical Production facility equipment/systems with direct experience with Solution Prep, Upstream, and Downstream purification equipment such as weigh and dispense equipment, solution preparation vessels, cell culture reactors, centrifugation, chromatography, viral filtration skids, and UFDF skids as well as other equipment needed to support these processes such as autoclaves, clean in place (CIP) systems, washers, clean steam, water for injection, etc. Ability to analyze problems, develop and propose engineering solutions in a scien