Manufacturing Systems Engineer: Automation - PLC
BioSpace
Manufacturing Systems Engineer: Automation–PLC We are seeking a Manufacturing Systems Engineer who will work with a team of automation engineers to build and maintain automation systems and platforms that support GMP drug substance plant operations. This role works closely with the capital project team to deliver robust automation systems for the new plant utility and standalone systems, including integration of various platforms, analytical problem‑solving, project management, lifecycle management, and operational excellence. Responsibilities Develop and maintain automation solutions using PLCs such as Allen Bradley, Siemens, etc., and integrate with the Emerson DeltaV system. Develop and maintain SCADA, Trailblazer reporting system, equipment PLCs, and interface hardware. Support standalone system implementation and start‑up; provide technical guidance in HMI layout and design including power distribution, grounding, I/O assignments. Work with process SMEs to understand key process requirements and translate them into digital automated solutions. Assist in continuous improvement and innovation initiatives to improve efficiency and sustainability of standalone systems. Collaborate with business partners to understand how standalone systems can improve workflow and productivity; synthesize requirements from clients, customers, and end‑users. Provide clear documentation for delivered solutions and processes; work closely with QA partners and support computerized systems validation processes in a GxP environment; maintain Data Integrity Assessments per Amgen and industry standards. Build business processes to support project scope aligned with timelines; develop detailed specifications and engineering policies and procedures affecting multiple units. Support functional area projects focused on improving process equipment/utilities/facilities and large capital projects to integrate new drug substance manufacturing technologies. Support technical root cause analysis, incident investigations, and troubleshooting on standalone systems. Support new product introductions or technology introductions by performing automation engineering assessments, implementing system configuration changes, and supporting qualification runs. Assist with day‑to‑day operational support including on‑call support, troubleshooting, preventative and corrective maintenance, and spare parts management. Stay curious and identify innovative ways to improve cost‑effectiveness and productivity. Qualifications Basic Qualifications High School Diploma / GED and 8 years of engineering experience Associate’s Degree and 6 years of engineering experience Bachelor’s Degree and 2 years of engineering experience Master’s Degree Preferred Qualifications Degree in Electrical Engineering, Computer Science, Chemical Engineering, or Biotech Engineering. Direct knowledge of PLC design; experience with controls engineering and troubleshooting in GMP biopharmaceutical facilities and utility equipment automation. Extensive experience programming, designing, installing, and managing standalone controls, PLCs, and field device/instrumentation technologies. Experience with Rockwell industrial automation hardware and systems, including troubleshooting, OPC, Foundation Fieldbus, Profibus, DeviceNet. Ability to apply GAMPs and GMPs and document in a regulated environment, including 21 CFR Part 11, ASTM 2500, S88, S95. Experience in capital project lifecycle management: design, scoping, cost estimation, business case, detailed design, documentation, and execution. Hands‑on experience developing process control strategies for new product introduction and technology deployment. Experience delivering continuous improvements that enhance safety, reliability, and productivity. Self‑directed team player who thrives in collaborative decision‑making culture. Strong technical writing, communication, and presentation skills. Benefits Includes competitive base salary and comprehensive total rewards aligned with local industry standards. Amgen supports professional and personal growth through a collaborative culture and well‑designed benefits. Equal Opportunity Employer 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 provide reasonable accommodation for applicants with disabilities. #J-18808-Ljbffr BioSpace
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