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.

BASIC QUALIFICATIONS:

• High school diploma / GED and 10 years of Maintenance or Engineering experience OR
• Associate’s degree and 8 years of Maintenance or Engineering experience OR
• Bachelor’s degree and 4 years of Maintenance or Engineering experience OR
• Master’s degree and 2 years of Maintenance or Engineering experience OR
• Doctorate degree

PREFERRED QUALIFICATIONS:

• Bachelor’s Degree in Engineering or related field.
• 6+ years’ experience in engineering or maintenance or related function within the biotechnology and/or pharmaceutical and/or Medical Device industry.
• 5+ years’ experience and track record of ensuring compliance in a highly regulated environment.
• Experience working in a regulated environment (e.g. cGMP, OSHA, EPA, etc.) and experience interacting with regulatory agencies and inspectors.
• Familiarity with GMP quality systems/processes such as change control, non-conformances, corrective and preventative actions, and qualifications/validation
• Solid understanding of the following routine engineering tasks and systems: Maintenance and asset management systems (e.g. IBM Maximo), building automation system operation, navigation, and reporting, vibration monitoring and analysis, equipment sizing, selection, installation, and maintenance, ductwork and piping sizing, design, installation, and maintenance, air handling system psychrometrics, Freezer and cold storage refrigeration systems, and equipment operation & maintenance (HVAC control systems, air handlers, fans, coils, humidifiers, filters and filtration, terminal devices, refrigeration equipment, compressors, chillers, pumps, cooling towers, boilers, HEPA filters, including testing & certification, fume hoods and biosafety cabinets, including testing & certification) and system and equipment trouble shooting.
• Technical experience with critical and non-critical utilities systems (such as HVAC serving Grade 7/8/9 manufacturing space, Clean Steam, Process Compressed Air, etc).
• Ability to work independently, handle multiple tasks in project settings, and proficiency in communication, facilitation, and collaboration.
• CEM (Certified Energy Managers) by Association of Energy Engineers is desirable.

Let’s do this. Let’s change the world. 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.

• Provide system ownership for Upstream Biopharmaceutical process equipment. Identify, support, and/or lead implementation of engineering-based improvements or upgrades to the equipment or facility systems. This may include development of business case for improvement and identification of design requirements and then translation of requirements into process equipment/system design, specification and supporting the construction, startup, and validation of equipment.
• Develop equipment maintenance programs, ensure the availability of spare parts, and coordinating maintenance activities to ensure systems are in proper working order.
• Ensure systems are installed and operating safety and stay in sync with pertinent environmental health/safety practice, rules and regulations.
• Ensure commissioning and qualification of systems is completed in alignment with GMP requirements and interact with regulatory inspectors.
• System guidance to identify performance risks and implement risk reduction strategies.
• Providing problem solving support to reduce production downtime. This will involve leading and/or supporting technical root cause analysis and implementation of corrective/preventive action.
• Support new product/technology introductions by performing engineering assessments, implementing equipment modifications, and supporting engineering runs.