Senior Manufacturing Systems Engineer - PLC Systems

Senior Manufacturing Systems Engineer (PLC) In this vital role as a member of the Facilities & Engineering (F&E) group, you will lead technical projects, drive innovation, and support PLC‑based processes and utility skid equipment automation needs. You will solve complex engineering problems and ensure the company’s engineering efforts align with strategic objectives. You will also provide leadership and guidance to the Automation Engineering team supporting 24/7 manufacturing and facility operations. You will partner closely with the capital project team to design, build, commission, and qualify new equipment and systems needed for drug substance production. This role will develop domain expertise to support operations upon start‑up, focusing on manufacturing automation. Job responsibilities include: Site design, construction, start‑up, and operational readiness Provide support to the capital project team with a strong focus on safety and on‑time facility start‑up. Collaborate with the site process engineering team to understand key process requirements and develop process control automation solutions for PLC‑based systems. Work with platform leads to ensure standalone PLC‑based systems are designed with the proper network connectivity and system‑to‑system communication to enable centralized monitoring and alarming. Support commissioning and qualification efforts including Automation Installation Verification/Automation Check Out (IV/ACO). Partner with various organizational units to support tasks including operational readiness, document reviews, deviation investigation and change controls. Develop and maintain detailed specifications, SOPs and operating standards that impact multiple organizational units. Provide mentoring to develop and accelerate site technical automation capabilities. Site Operations Act as system owner for standalone PLC‑based systems. Manage day‑to‑day operational support including 24×7 onsite/on‑call operational support, troubleshooting support to plant and manufacturing operations, preventive and corrective maintenance, system administration, and automation system spare parts management. Lead and support functional area projects focused on improving equipment/utilities/facilities as well as 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. Prepare and review Standard Operating Procedures (SOP) and cGMP documents. On‑site and up to 10% domestic/international travel. 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 the following 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 or Computer Science, Chemical Engineering or Biotech Engineering. Extensive experience with process and utility skid equipment, and direct knowledge of integrating various OEM automation software and field instrumentation technologies such as Rockwell platforms. Direct knowledge of integrating various OEM automation software and field instrumentation technologies. Direct knowledge of Automation System design, experience in Process control engineering and troubleshooting with GMP biopharmaceutical production facility equipment/systems automation. Experience in programming, design, installation and lifecycle management of PLC and field device/instrumentation technologies. Extensive understanding and background in programming, design, installation and lifecycle management of manufacturing process controls, automation and field instrumentation technologies. In‑depth knowledge of industry standards such as 21 CFR Part 11, ASTM 2500, S88, S95, GAMP, GDP, and GMP. Experience in Capital Project Lifecycle Management including conceptual design, basis of design, detailed design, implementation, and validation. 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. What you can expect of us From competitive benefits to a collaborative culture, we support your professional and personal growth and well‑being. In addition to the base salary, Amgen offers competitive and comprehensive total rewards plans that are aligned with local industry standards. 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 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. #J-18808-Ljbffr Initial Therapeutics, Inc.