Manufacturing Systems Engineer: Automation   (Swing Shift Monday - Friday)

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

Let’s   change the world . As a   Manufacturing Systems   Engineer,   you will   work with 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 :   Swing  Shift 3 pm - 11pm: Monday through Fri 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.

Responsibilities

• Develop and   maintain   the process control system on Emerson   DeltaV   distributed control system (DCS) .
• Collaborate with key stakeholders and end-users to understand and synthesize key process requirements, and to develop solutions using Amgen standard automation platform for process automation systems .
• Provide clear documentation for delivered solutions and   processes .
• Support QA partners in performing computerized systems validation in a   GxP   environment.
• Perform Data Integrity Assessments (DIA)   in accordance with   the current Amgen and industry standards.
• Support   process automation   systems   to ensure design aligns with Amgen specifications, incorporates the latest technology, and meets safety requirements .
• Support vendor FAT to ensure that control strategy and software code meet Amgen requirements .
• Develop and   maintain   engineering and maintenance documentation, and associated procedures for delivered solutions and processes .
• Support commissioning and qualification efforts including Automation Installation Verification/Automation Check Out (IV/ACO) in a fast-paced environment.
• Site Operations
• O wn and driv e   to   completion   Change Controls, CAPAs, and Deviations .
• S upport   technical root cause analysis, incident investigations, and troubleshooting .
• S upport functional area projects focused on improving process equipment ,   utilities,   and   facilities as well as large capital projects to integrate new drug substance manufacturing technologies into the facility .
• Drive continuous improvement for   process automation systems   to improve operational workflows, safety, reliability, efficiency, and sustainability .
• Support   day-to-day   o peration s   including rotational on - call   s upport .
• 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. What we expect   from   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 8 years of Engineering experience OR
• Associate’s Degree   and 6 years of Engineering experience OR
• Bachelor’s Degree and 2 years of Engineering experience OR
• Master’s Degree

Preferred Qualifications

• Degree in Electrical Engineering ,   Computer Science, Chemical Engineering ,   Biotech Engineering,   or related   field .
• Direct knowledge of Automation System design, experience in process control engineering and troubleshooting with GMP biopharmaceutical production facility equipment/systems automation such as media, harvest, bioreactors,   solution prep,   s ingle 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.
• E xperience   in   programming ,   installation ,   and lifecycle management of automation and field instrumentation technologies .
• Experience   in programming, design, installation and lifecycle management of manufacturing process controls,   and   automation and field instrumentation technologies.
• Experience with Emerson   DeltaV   DCS system   and   ability to perform advanced troubleshooting ,   and s ystem   i ntegration using OPC, Foundation Fieldbus,   and   Profibus   technologies .
• 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 .
• Self -directed team player   able to work cross-functionally .
• Strong technical writing and communication   skills . What you can expect from 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.   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 a

Total Rewards

Plan based on eligibility that may include:

• A c omprehensive 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 105,362.60USD -142,549.40 USD