Senior Manufacturing Systems Engineer: Automation  (Wednesday - Saturday Shift)

Career Category Engineering Job Description HOW MIGHT YOU DEFY IMAGINATION? If you feel like   you’re   part of something bigger,   it’s   because you are. At Amgen, our shared mission—to serve patients—drives all that we do.

It is key to our becoming one of the world’s leading biotechnology companies. We are global collaborators who achieve together—researching, manufacturing, and delivering ever-better products that reach over   10 million patients   worldwide. It’s   time for a career you can be proud of.

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. Senior Manufacturing Systems Engineer :   Automation - DeltaV Live What you will do Let’s   do this.

Let’s   change the world . As   a   Senior   Manufacturing Systems   Engineer ,   you will provide automation technical leadership to a group of   a utomation   e ngineers   who   are responsible for   building and   maintaining   various automation systems and platforms that support the GMP Drug Substance Plant Operations. *The schedule for this position will be: 4 days x   10 hour  shift: Wednesday through Satur day.* In this vital role as a member of the Facilities & Engineering (F&E) Automation   team  you will work hand in hand with the capital project team to deliver robust   process   automation systems to   operate   the new plant. This includes complex and challenging system automation initiatives that require solid understanding of various automation platforms, integration between different platforms, analytical problem-solving techniques, project management, lifecycle   management   and Operational Excellence.

Responsibilities

• Develop and   maintain   the process control system on   Emerson   DeltaV   distributed control   system   (DCS) .
• Work with process subject matter experts (SMEs) to understand key process requirements and transform them into digital automated solutions .
• Collaborate with business partners to understand   how   automation   can improve workflow and productivity .    Synthesize requirements from clients,   customers   or end-users to develop the best automation solutions.
• Provide clear documentation for delivered solutions and processes; work closely with QA partners while supporting computerized systems validation processes in a   GxP   environment .    Maintain Data Integrity Assessments with the current Amgen and Industry standards.
• Build the business processes to support the   project   scope in alignment with project timelines. Develop detailed   specification   and engineering policies and procedures that affect multiple organizational units.
• Support commissioning and qualification efforts including Automation Installation Verification/Automation Check Out (IV/ACO) in a fast-paced environment.
• On-going operations:
• Own and drive to   completion   Change Controls, CAPAs, and Deviations.
• Lead and support functional area projects focused on improving process   equipment/utilities/facilities   as well as large/sophisticated capital projects to integrate new drug substance manufacturing technologies into the facility.
• Lead   and   support technical root cause analysis, incident investigations, and   troubleshooting on   process control issues related to plant operations.
• Lead and support new product introductions (NPI) or   new technology   introductions by performing   automation   engineering assessments, implementing   automation   system configuration   changes ,   and supporting engineering and process qualification runs as applicable.
• Manage Day-to-day Operational Support including: 24 x 7 Onsite/On Call Operational Support, Troubleshooting Support to Plant and Mfg. Operations,   Process and   Utility   Automaton   system s,   Preventive and   C orrective   M aintenance,   S ystem   A dministration,   and   Automation System   spare parts management .
• Prepare/review Standard Operating Procedures (SOP) and cGMP documents.
• Be constantly curious and feed your passion and interests in groundbreaking technology. Use your given time to look for new and innovative ways to do business differently, better, and more cost effectively. Win What we expect of you We are all different, yet we all use our unique contributions to serve patients. The automation professional we   seek   is an engineer with these qualifications.

Basic Qualifications

• High School Diploma / GED and   10   years of Engineering experience OR
• Associate’s Degree   and   8   years of Engineering experience OR
• Bachelor’s Degree and   4   years of Engineering experience OR
• Master’s   Degree and   2   years of Engineering experience OR
• Doctorate   Degree

Preferred Qualifications

• Degree in Electrical Engineering, Computer Science, Chemical Engineering, Biotech Engineering, or related   field .
• Direct knowledge of Automation System design, experience in   p rocess control engineering and troubleshooting with GMP biopharmaceutical production facility equipment/systems automation   such as   media, harvest, bioreactors, solution prep, single use mixing vessels, chromatography, TFFL/TFFX, viral filtration, viral inactivation, UF/DF, depth filtration, drug substance fill, CIP/SIP, clean utilities, and integrating various OEM automation software .
• Extensive understanding and background in programming, design, installation and lifecycle management of manufacturing process controls,   automation   and field instrumentation technologies.
• Experience with Emerson   DeltaV   DCS system, Process Control Network design including network segregation,   v irtual   i nfrastructure design and implementation ,   and ability to perform advanced troubleshooting activities ,   s ystem   i ntegration using OPC, Foundation Fieldbus, Profibus, and   DeviceNet   technologies.   Experience with   DeltaV   Live is preferred.
• Ability to interpret and apply GAMPs and GMPs and familiarity with documentation in a highly regulated environment   with requirements such as 21 CFR Part 11, ASTM 2500, S88, and S95.
• Experience in Capital Project Lifecycle Management: Conceptual Design, Scope and cost estimate development, business case development, detailed design, engineering and validation documentation and project execution.
• Demonstrated hands-on experience in developing process control strategies for New Product Introduction and New Technology Deployment for Drug Substance Plant Operations.
• Demonstrated experience with continuous improvements resulting in enhanced safety, system reliability, and productivity ( e.g.  cycle times, and reduced plant utilities usage etc.) related to Drug Substance Plant Operations.
• The ideal individual must be a self-directed team player ready 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. Thrive What you can expect of us As we work to develop treatments that take care of others, we also work to care for our teammates’ professional and personal growth and well-being. Amgen offers a

Total Rewards

Plan   comprising   health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities including:

• Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts.
• A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
• Stock-based long-term incentives
• Award-winning time-off plans and bi-annual company-wide shutdowns
• Flexible work models, including remote work arrangements, where possible. Apply now for a career that defies imagination In our quest to serve patients   above all else , Amgen is the first to imagine, and the last to doubt. Join us. careers.amgen.com #AmgenNorthCarolina . Salary Range 136,906.95USD -185,227.05 USD