Mfg. Systems Engineer

• Serve as a subject matter expert in PLC Configuration, SCADA, and other manufacturing IT system technologies.
• Execute AML-14 Filling and Inspection automation standard work practices attained to automation workstream deliverables.
• Lead system implementation, configuration, and support activities across production environments for automation systems.
• Collaborate with multi-functional teams to define system requirements and ensure alignment with operational goals.
• Monitor system performance and seek opportunities for optimization and automation of manufacturing systems.
• Ensure system compliance with cGMP, data integrity, and cybersecurity requirements.
• Participate in system validation and change control processes, ensuring documentation accuracy.
• Analyze system data to support investigations, performance reviews, and strategic decision-making.
• Provide technical support and training to system users, promoting adoption and best practices.
• Stay informed on emerging technologies and digital trends in manufacturing systems.
• Contribute to SOP development and revisions related to system operations and compliance.
• Promote a culture of digital innovation, collaboration, and operational excellence.

Bachelor’s degree in engineering and 2 years of Manufacturing Systems/Automation experience, * Experience with Manufacturing Execution Systems (MES) and SCADA platforms.

• Strong background in manufacturing IT systems, automation, and digital manufacturing technologies.
• Experience leading system implementation, configuration, integration, and support in a manufacturing environment.
• Knowledge of pharmaceutical, biotechnology, or regulated manufacturing operations.
• Understanding of cGMP regulations, data integrity requirements, and compliance standards.
• Experience with computer system validation (CSV) and change control processes.
• Knowledge of cybersecurity principles and their application within manufacturing systems.
• Ability to analyze and interpret manufacturing system data to drive operational improvements and support investigations.
• Experience with process optimization, automation initiatives, and continuous improvement projects.
• Problem Solving Skills and experience in troubleshooting techniques
• Strong project management skills, including managing timelines, stakeholders, and cross-functional teams.
• Experience collaborating with engineering, manufacturing, quality, validation, and IT teams.
• Ability to develop and revise Standard Operating Procedures (SOPs) and technical documentation.
• Experience providing technical support, user training, and system troubleshooting.
• Familiarity with Industry 4.0, digital transformation, and smart manufacturing technologies.
• Strong communication, problem-solving, and leadership skills.
• Experience in highly regulated environments such as biopharmaceutical, pharmaceutical, medical device, or GMP manufacturing facilities., Automation, Automation Systems, Best Practices, Biotech and Pharmaceutical, Change Control, Communication Skills, Computer Skills, Computer Systems, Continuous Improvement, Cross-Functional, Current Good Manufacturing Practice (cGMP), Customer Acquisition, Data Analysis, Data Quality, Disease, Documentation, Emerging Technology, GMP (Good Manufacturing Practices), Identify Issues, Information Technology & Information Systems, Internet Security, Interviewing Skills, Leadership, Maintain Compliance, Manufacturing, Manufacturing Analysis, Manufacturing Automation, Manufacturing Execution Systems (MES), Manufacturing Operations, Manufacturing Systems, Medical Equipment, Medical Products, Medicine, Oncology, Operational Improvement, Operational Support, Performance Analysis, Performance Reviews, Problem Solving Skills, Process Improvement, Production Support, Production Systems, Programmable Logic Controller (PLC), Project/Program Management, Regulations, Regulatory Compliance, Requirements Management, Standard Operating Procedures (SOP), Standards Development, Supervisory Control and Data Acquisition (SCADA), System Operations, System Validation, Systems Administration/Management, Systems Analysis, Systems Engineering, Team Player, Technical Support, Technical Training, Technical Writing, Time Management

As we work to develop treatments that take care of others, we also work to care for our teammates’ professional and personal growth and well-being.

In addition to the base salary, Amgen offers a Total Rewards Plan comprising 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 including:

• A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental & vision coverage, and life & disability insurance
• 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 and an annual site shutdown
• Flexible work models where possible. Refer to the Work Location Type in the job posting to see if this applies.

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 lie within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career., 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 At Amgen, we believe in a “biology first” approach. We use cutting-edge science and technology to study the subtlest biological mechanisms in search of therapies that will improve the lives of those who suffer from serious diseases. Amgen believes the cure for disease can be found inside each and every one of us.

Company Size: 10,000 employees or more