Career CategoryEngineering
Job DescriptionMANUFACTURING SYSTEMS ENGINEERWhat you doLet's do this. Let's change the world. In this vital role you will support manufacturing technology and automation systems, implementation, and optimization of digital manufacturing systems, enable data-driven operations and ensure compliance with regulatory and cybersecurity standards.
Specific responsibilities include but are not limited to:- 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.
What we expect from youWe are all different, yet we all use our unique contributions to serve patients. The Mfg. Systems Engineer professional we seek is a highly tech individual with these qualifications.
Basic Qualifications:Bachelor's degree in engineering and 2 years of Manufacturing Systems/Automation experience
Preferred Qualifications- 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.
What you can expect from usAs 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.
Apply now and make a lasting impact with the Amgen team.careers.amgen.comIn 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.
SponsorshipSponsorship of this role is not guaranteed.
