Location: Holly Springs,NC, USA
Join Amgen's Mission of Serving PatientsAt 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 2027Senior Automation Engineer - Delta V SpecialistWhat you will doIn this 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 automation systems to operate the new plant. This includes complex and ambitious system automation initiatives that require a wide range understanding of various automation platforms, integration between different platforms, analytical problem-solving techniques, project management, lifecycle management and Operational Excellence.Project construction, start-up, and operational readiness:Develop and maintain process control automation solutions applying DeltaV Distributed Control System (DCS), Human Machine Interfaces (HMI), Building Management Systems (BMS), and Supervisory Control and Data Acquisition systems (SCADA).Work with process subject matter experts (SMEs) to understand key process requirements and transform them into digital automated solutionsCollaborate 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.Ongoing operations: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/support technical root cause analysis, incident investigations, and solving problems 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 Mfg. Operations, Automation System Administration, Automation System Operating Systems (OS) HotFix assessments and rollout, Preventative and corrective maintenance, and Automation System spare parts managementBe constantly curious and feed your interest 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 of youWe are all different, yet we all use our unique contributions to serve patients. The engineering professional we seek enjoys challenges and is motivated to help serve patients with these qualifications.Basic Qualifications:Doctorate degreeORMaster's degree and 3 years of Engineering experienceORBachelor's degree and 5 years of Engineering experienceORAssociate's degree and 10 years of Engineering experienceORHigh school diploma / GED and 12 years of Engineering experiencePreferred Qualifications:Degree in Electrical Engineering or Computer Science, Chemical Engineering or Biotech Engineering.Direct knowledge of Automation design, experience in process control engineering and solving problems with GMP biopharmaceutical production facility equipment/systems such as media, harvest, bioreactors, chromatography, vial filtration, and ultrafiltration/diafiltration, 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 Delta-V DCS system, Process Control Network design including network segregation, Process Control Systems: Virtual Infrastructure design and implementation and ability to perform troubleshooting activities with Amgen IS, System Integration using OPC, Foundation Fieldbus, Profibus, and DeviceNet 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.Experience in Capital Project Lifecycle Management: Conceptual Design, Scope and cost estimate development, case development, detailed design, engineering and validation documentation and project implementation.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 teammate 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.Ability for domestic/international travelWhat you can expect from usAs 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 a Total Rewards Plan, based on eligibility, comprising of 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 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 accountsA discretionary annual bonus program, or for field sales representatives, a sales-based incentive planStock-based long-term incentivesAward-winning time-off plansFlexible work models, including remote and hybrid work arrangements, where possibleApply nowfor a career that defies imaginationObjects in your future are closer than they appear. Join us.careers.amgen.comApplication deadlineAmgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position.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. Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.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.