Senior Manufacturing Systems Engineer

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 lay within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career. Senior Manufacturing Systems Engineer - Automation What you will do Let’s do this Let’s change the world In this role as a member of the Amgen Manufacturing & Clinical Supplies – Facilities & Engineering (MCS-F&E) Automation team you will support Clinical & Commercial Drug Product Plant Automation. This includes sophisticated and complicated system automation initiatives that require proven understanding of various automation platforms, integration between different platforms, analytical problem-solving techniques, critical thinking, project management, lifecycle management and Operational Excellence. Responsibilities: Developing process control applications utilizing Programmable Logic Controllers (PLC), Distributed Control Systems (DCS), Human Machine Interfaces (HMI) and Supervisory Control and Data Acquisition systems (SCADA). Support projects focused on improving process equipment/utilities/facilities -to- sophisticated unit operation skids to integrate new drug product manufacturing technologies into clinical/commercial facility. Support of capital projects. This role involves the application of advanced automation engineering principles in the design, specification, construction, startup, and validation of process equipment and systems for capital projects of significant scope and complexity. Demonstrated understanding of project life cycles is preferred. Candidate should be familiar with engineering processes from initial conceptualization through project turnover to operations. Familiarity with industry standards for batch control systems, software development life cycle methodologies, 21 CFR Part 11, and GAMP. Development of detailed specification, engineering documents, SOP and operating standards. Ownership and administration of process control automation in a GMP regulated manufacturing setting. Engage in, and process change control requests per established SOP and processes. Lead technical root cause analysis, incident investigations, and troubleshooting on process control issues related to electrical, instrumentation and control systems. Design and testing of automation based process equipment. Support new product introductions or new technology introductions by performing engineering assessments, implementing automation system configuration changes and supporting engineering runs. Devise new approaches to complex problems through adaptations and modifications of standard automation technical principles. Support a safe working environment by complying with all pertinent environmental health/safety practice, rules and regulations What we expect of you We are all different, yet we all use our unique contributions to serve patients. The dynamic professional we seek is an individual with these qualifications. Basic Qualifications: High school diploma / GED and 10 years of Manufacturing Automation Engineering experience OR Associate’s degree and 8 years of Manufacturing Automation Engineering experience OR Bachelor’s degree and 4 years of Manufacturing Automation Engineering experience OR Master’s degree and 2 years of Manufacturing Automation Engineering experience OR Doctorate degree Preferred Qualifications: B.S or M.S. in Electrical Engineering, Chemical Engineering, Mechanical Engineering, or Biotech Engineering. Strong control system automation background focused specifically in design, installation, programming and validation of automated processes are essential. 5+ years combined experience with Rockwell Automation Factory Talk & ControlLogix PLC Platform. Ability to create, update and read electrical design packages including SDS, URS, IQ, OQ and VSR among other engineering and validation documentation. Knowledge of ASTM 2500, S88 and S95 techniques. Batch processing a desired advantage. Strong leadership, technical writing, and communication/presentation skills are required. Work schedule flexibility as required to support 24/7 operations, requiring occasional after-hours engineering coverage. Experience in developing automation strategies for New Product Introduction and New Technology Deployment. Preferred Experience using Lyophilizer System, Filling systems for Syringe and Vials and Building Management System Position requires a working knowledge of building automation systems, electronic batch records, PLC, OPC, Foundation Fieldbus, Profibus, Ethernet/IP and DeviceNet technologies. Working knowledge and experience with cGMP procedures and engineering practices on pharmaceutical/biotech production processes, facilities, and equipment. Candidate should be experienced in change control, nonconformance, corrective and preventative actions, and validation practices. Must be independent, self-motivated, organized, able to multi-task in project environments, and skilled in communication, facilitation, and collaboration. Individual must be a team player prepared to work in and embrace a team-based culture that relies on collaboration for effective decision-making. 5+ years’ combined experience with the following: Rockwell Automation SCADA and PLC Platform. iFix SCADA Platform Process Control Network design. Virtual Infrastructure design and implementation and ability to perform sophisticated trouble shooting activities. What you can expect from us As 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. The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications. 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 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 Flexible work models, including remote and hybrid work arrangements, where possible Apply now for a career that defies imagination Objects in your future are closer than they appear. Join us. careers.amgen.com In any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information. 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.