Mfg. Systems Engineer - Automation Engineer

Job description

Career CategoryEngineeringJob DescriptionJoin 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. Manufacturing Systems (Automation) Engineer What you will do Let’s do this. Let’s change the world. At Amgen we are committed to being science-based and follow a continuous learning approach to advancing science, driving discovery, and igniting innovation that works to help reduce disease. It is in this context that we endorse an inclusive and diverse workforce that helps drive scientific innovation and problem-solving, leading to better solutions that benefit both patients and society. Based in New Albany, Ohio, the site of Amgen’s new advanced product assembly and packaging plant, this role will apply advanced and diverse engineering principles to the design and implementation of major system modifications, experiments, processes, and/or capital projects. The work schedule for this role will be a 12-hour, 6 PM to 6 AM, 2-2-3 schedule (to support coverage across Amgen’s 24-hour operations). These shift structures can be a great opportunity to better support individual work/life priorities. Key Responsibilities: System Design and Development: Design and develop automation systems and control strategies for packaging machinery and processes. Implement and configure Programmable Logic Controllers (PLCs), Human-Machine Interfaces (HMIs), and other automation equipment. Create and maintain detailed documentation, including system specifications, design documents, and operational procedures. Integration and Optimization: Integrate new automation technologies and equipment into existing packaging systems. Optimize control processes to enhance efficiency, reduce waste, and improve product quality. Conduct feasibility studies and cost-benefit analyses for automation projects. Troubleshooting and Support: Diagnose and resolve issues with automation systems and control equipment. Provide technical support and troubleshooting for production and maintenance teams. Perform system upgrades and maintenance to ensure optimal performance and reliability. Compliance and Quality Assurance: Ensure that all automation systems comply with FDA regulations, GMP standards, and industry best practices. Collaborate with Quality Assurance and regulatory teams to address any compliance or quality issues related to automation. Project Management: Lead and manage automation projects, including planning, execution, and monitoring. Coordinate with cross-functional teams to ensure timely and successful project completion. Prepare and present project reports, performance metrics, and technical documentation. Training and Development: Train and support staff on the use and maintenance of automation systems. Develop training materials and conduct workshops to enhance team competency in automation technologies. The position is a key role in the Engineering and Maintenance department and the candidate must manage and apply extensive technical expertise in the coordination of multiple, sophisticated, non-routine projects involving the planning, design, reconfiguration, construction, maintenance, validation and alteration of systems, facilities and processes. This position will also be required to apply advanced and diverse engineering principles to more than one area of engineering (process, unit operations, equipment, devices and materials) in complex process characterization, optimization, scale up or manufacturing support projects. Production Support Key responsibilities will include working with the engineering and maintenance team to support the commercial production packaging lines. Additional responsibilities will include providing technical operations support for continuously improving the packaging lines' capacity and performance and advising on technical improvement projects. The Engineer must ensure effective communication throughout the Amgen commercial site network with all stakeholders and deliver on technical improvements. What we expect of you We are all different, yet we all use our unique contributions to serve patients. The professional we seek will possess these qualifications: Basic Qualifications: Master’s degree Or Bachelor’s degree and 2 years of Automation experience in Pharmaceutical, Medical Devices, or Biotechnology industries Or Associate’s degree and 6 years of Automation experience in Pharmaceutical, Medical Devices, or Biotechnology industries Or High school diploma/GED and 8 years of Automation experience in Pharmaceutical, Medical Devices, or Biotechnology industries Preferred Qualifications: Advanced degree in Mechatronics, Computer, Electrical, Mechanical, or Chemical Engineering Knowledge and/or experience of pharmaceutical/biotech processes, especially in the area of final drug product operations Knowledge in Data Integrity and Security Extensive understanding and background in programming, design, installation, validation, and lifecycle management of manufacturing process controls, automation, field instrumentation technologies Proficiency in Machine Vision, Serialization, Robotics, Siemens, and Rockwell software platform Ability to interpret and apply GAMPs and GMPs and familiarity with documentation in a highly regulated environment Comprehensive understanding of validation protocol execution requirements as well as knowledge of validation processes and requirements as applied to new equipment installations Organizational, project management, problem-solving, as well as validation protocol, and technical writing capability Excellent communication (verbal/written) and presentation skills Demonstrated interpersonal skills, including: collaboration, influencing, and facilitation Understanding of Operational Excellence and Lean Transformation in the Automation and Engineering Context What you can expect of 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. 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