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Manufacturing Systems Engineer: Automation - Delta V
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Full-time
high school, associate degree, bachelor degree, postgraduate degree
Retirement And Savings Plan, Medical Insurance, Dental Insurance, Vision Insurance, Life Insurance, Disability Insurance
Posted 27d ago
~40 hrs/week
Responsibilities
Develop and maintain process control systems using Emerson DeltaV DCS to support GMP Drug Substance Plant Operations. Collaborate with stakeholders to deliver robust automation solutions and ensure compliance through validation and documentation.
Requirements
Requires a minimum of a High School Diploma with 8 years of experience, or a Bachelor's degree with 2 years of engineering experience. Preferred candidates have a degree in Electrical, Computer, Chemical, or Biotech Engineering and direct experience with DeltaV and biopharmaceutical production systems.
Full job description
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 withinthem, 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 - Delta V
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 automation engineers who are responsible for building and maintaining various automation systems and platforms that support the GMP Drug Substance Plant Operations.
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 robustprocess 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
Own and drive to completion Change Controls, CAPAs, and Deviations.
Support technical root cause analysis, incident investigations, and troubleshooting.
Support 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 operations including rotational on-call support.
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, 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.
Experience 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 DCSsystem and ability to perform advanced troubleshooting, andsystem integration 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 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
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Salary Range
USD - USD
Related keywords
Emerson DeltaVDCSAutomationGMPGxPBiopharmaceuticalIndustry 4.021 CFR Part 11ASTM 2500S88S95OPCFoundation FieldbusProfibusGAMPCIP/SIP
Amgen harnesses the best of biology and technology to fight the world’s toughest diseases, and make people’s lives easier, fuller and longer. We helped establish the biotechnology industry, and we remain on the cutting-edge of innovation, using technology and human genetic data to push beyond what’s known today. Our investment in research and development has yielded a robust pipeline that builds on our existing portfolio of medicines to treat cancer, heart disease, osteoporosis, inflammatory diseases and rare diseases.
Amgen is one of 30 companies comprising the Dow Jones Industrial Average®, and part of the Nasdaq-100 Index®. In 2024, Amgen was named one of the “World’s Most Innovative Companies” by Fast Company and one of “America’s Best Large Employers” by Forbes.
For more information, visit Amgen.com and follow us on X, LinkedIn, Instagram, TikTok, YouTube and Threads.
🔗 Community Guidelines: https://wwwext.amgen.com/community-guidelines
🔗Global Privacy Statement Directory: www.amgen.com/dp
Special Advisory: Please be cautious of scam recruitment offers claiming to be from Amgen. Such scams may come from various sources, including fake websites and/or unsolicited emails and seek to obtain personal data or payment from victims by offering jobs that do not exist. Please be advised that Amgen would never ask for payment to progress a job application. When in doubt, please check to see if the position in question is posted on this website before applying. Additionally, please report any suspicious recruiting activity to https://complaint.ic3.gov/ and thank you for your assistance.
Offices: One Amgen Center Drive, Thousand Oaks, CA 91320, US · 1120 Veterans Blvd, South San Francisco, CA 94080, US · 34 Commerce Way, Woburn, MA 01801, US · Avenida Calle 100 7-81, Bogota, Bogota, D.C. 110221, CO · Minervum 7061, Breda, North Brabant 4817 ZK, NL
BiologicsHuman therapeuticsand Development of novel productsHuman ResourcesHealth DiagnosticsHealth CareProfessional ServicesBiotechnologyManufacturingPharmaceutical
Amgen harnesses the best of biology and technology to fight the world’s toughest diseases, and make people’s lives easier, fuller and longer. We helped establish the biotechnology industry, and we remain on the cutting-edge of innovation, using technology and human genetic data to push beyond what’s known today. Our investment in research and development has yielded a robust pipeline that builds on our existing portfolio of medicines to treat cancer, heart disease, osteoporosis, inflammatory diseases and rare diseases.
Amgen is one of 30 companies comprising the Dow Jones Industrial Average®, and part of the Nasdaq-100 Index®. In 2024, Amgen was named one of the “World’s Most Innovative Companies” by Fast Company and one of “America’s Best Large Employers” by Forbes.
For more information, visit Amgen.com and follow us on X, LinkedIn, Instagram, TikTok, YouTube and Threads.
🔗 Community Guidelines: https://wwwext.amgen.com/community-guidelines
🔗Global Privacy Statement Directory: www.amgen.com/dp
Special Advisory: Please be cautious of scam recruitment offers claiming to be from Amgen. Such scams may come from various sources, including fake websites and/or unsolicited emails and seek to obtain personal data or payment from victims by offering jobs that do not exist. Please be advised that Amgen would never ask for payment to progress a job application. When in doubt, please check to see if the position in question is posted on this website before applying. Additionally, please report any suspicious recruiting activity to https://complaint.ic3.gov/ and thank you for your assistance.
Offices: One Amgen Center Drive, Thousand Oaks, CA 91320, US · 1120 Veterans Blvd, South San Francisco, CA 94080, US · 34 Commerce Way, Woburn, MA 01801, US · Avenida Calle 100 7-81, Bogota, Bogota, D.C. 110221, CO · Minervum 7061, Breda, North Brabant 4817 ZK, NL
BiologicsHuman therapeuticsand Development of novel productsHuman ResourcesHealth DiagnosticsHealth CareProfessional ServicesBiotechnologyManufacturingPharmaceutical