Senior Manager Manufacturing Systems Engineering

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 single use 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. Senior Manager Manufacturing System Engineer ing What you will do Let’s   do this!   Let’s   change the world! In this vital role, you will oversee the   A utomation   E ngineering team, lead technical projects, and drive innovation and   support   manufacturin g’s   automation needs . You will solve complex engineering problems   and ensure the company's engineering efforts align with strategic   objectives . You will also provide leadership and guidance to the   Automation E ngineering team supporting 24/7 manufacturing and facility operations. The   Senior   Manager   Manufacturing System Engineer ing   will join the Facilities & Engineering (F&E) group   reporting to the   Facilities & Engineering (F&E)   Director . This role will partner   closely with the corporate engineering team   during the   design, build, commission ing , and qualif ication phases .   This role will be instrumental in developing automation domain   expertise   and supporting operational readiness   and   will develop domain   expertise   to support operations upon start-up, focusing on   manufacturing automation   as well as hiring and training the staff required to support startup and operations. Site   design,   construction, start-up, and operational readiness:

• Build and l ead a team of   Automation e ngineer ing   professionals and serve as the main point of contact for   the Automation engineering function .
• Support design review s while   partnering closely with the corporate engineering team .
• Execute and   support t he   commissioning and qualification of   process equipment   automation   in alignment with GMP requirements , while working in partnership with global engineering during site installation. E nsure their operational capability is aligned with manufacturing requirements and GMP regulation and on-time project delivery.
• Collaborate   with   the site   process   engineering team   to understand key process requirements and   d evelop process control automation solutions   primarily   utilizing   Emerson   DeltaV   Distributed Control System (DCS).
• Support commissioning and qualification efforts including Automation Installation Verification/Automation Check Out (IV/ACO).
• Partner with various organizational units to support tasks including operational readiness, document reviews, deviation   investigation   and change controls.
• Provide mentoring to   develop   and accelerate   site   technical   automation   capabilities . ​ Site   O perations:
• Lead a team of Automation engineer professionals and serve as the main point of contact for Automation engineering function.
• Accountable for Automation System Administration, Automation System Operating Systems (OS) and   HotFix   assessments and rollout, preventative and corrective   maintenance,  Automation   System spare parts management, and ownership of departmental Standard Operating Procedures (SOPs).
• Manage   d ay-to-day   automation   s upport including 24 x 7   o nsite/ o n -c all   s upport , troubleshooting,   and   daily   manufacturing and engineering   meetings .
• Establish clear expectations and priorities   to   staff. Encourage a culture of continuous improvement, partnership, and knowledge sharing.   Provide   development opportunities, feedback, and actively listen to staff .
• Effectively collaborate with key customers and support groups ( e.g.   Manufacturing, Quality, Process Development, Maintenance, network partners)
• Perform   automation   change   assessments, implement automation system configuration changes ,   and support   engineering and process qualification runs .
• Represent automation in cross-functional design reviews and audits .
• Look for new and innovative ways to do business differently,   better   and more cost effectively.
• Lead continuous improvement initiatives including improvements to safety, reliability, efficiency, and sustainability.
• Perform and   m aintain   d ata   i ntegrity   in accordance   with   the current Amgen and   i ndustry standards .
• Provide technical support to troubleshoot,   identify   and resolve process and system issues as needed.
• Provide strategic ,   tactical management ,   and leadership   to ensure   24x7 day-to-day   reliability of plant operations .
• Participate in the budgeting process for   Automation engineering , including forecasting costs, managing expenditures, and ensuring efficient allocation of resources.
• Up to   10% domestic/international travel ​ What we expect of you We are all different, yet we all use our unique contributions to serve patients. The   automation   professional we   seek   enjoys challenges and is motivated to help serve patients with these qualifications.

Basic Qualifications

• High school diploma / GED and 12 years of engineering experience OR
• Associate’s degree and 10 years of engineering experience OR
• Bachelor’s degree and 8 years of engineering experience OR
• Master’s degree and 6 years of engineering experience OR
• Doctorate degree and 2 years of engineering experience And
• In addition to meeting at least one of the above requirements, you must have a minimum of 2 years experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation or resources. Your managerial experience may run concurrently with the required technical experience referenced above

Preferred Qualifications

• Degree in Electrical Engineering ,   Computer Science, Chemical Engineering or Biotech Engineering.
• Extensive experience with Emerson   DeltaV , Process Control Network design including network segregation, Process Control Systems: Virtual Infrastructure design and implementation, System Integration using OPC, Foundation Fieldbus, and Profibus.
• Hands   on experience with IO-Link technology for smart sensor/actuator integration in automated manufacturing environments.
• Familiarity with Process Analytical Technology (PAT) tools and strategies for real-time process   monitoring   and control in biopharmaceutical manufacturing.
• Direct knowledge of integrating various OEM automation software and field instrumentation technologies.
• In-depth knowledge of   industry standards   such as 21 CFR Part 11, ASTM 2500, S88 ,   S95 ,   GAMP ,   GDP,   and GMP.
• Experience working in a regulated environment ( e.g.   cGMP, OSHA, EPA, etc.), experience interacting with regulatory agencies and inspectors, and familiarity with GMP quality systems/processes such as change control, non-conformances, corrective and preventative actions, and qualifications/validation
• Experience with Tech Transfer, Process Design, and Commissioning & Qualification.
• Direct knowledge of biopharmaceutical production facility with direct experience with Upstream (Seed train, production Bioreactors, Harvest), and Downstream Purification ( e.g.   Chromatography and viral Filtration skids, UFDF), and CIP/SIP Skids.
• Ability and w illingness to   mentor and develop engineering   staff and   embrace a team-based culture that relies on collaboration for effective decision-making.
• Strong leadership, technical writing, and communication/presentation skills.
• Work schedule flexibility as   required   to support 24/7 operations, requiring occasional after-hours engineering coverage ​ What you can expect of us As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we’ll support your journey every step of the way. In addition to the base salary, Amgen offers competitive and comprehensive

Total Rewards

Plans that are aligned with local industry standards. Apply now and make a lasting impact with the Amgen team! careers.amgen.com 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 and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.

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, disability status, or any other basis protected by applicable law. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation. .

Salary Range 163,288.40USD -220,919.60 USD