Sr. Systems Engineer - Project Delivery Lead

Amgen; Juncos (PR); On-site; USD 140,000 - 180,000; Full time

Job summary

Amgen is seeking a Sr. Systems Engineer - Project Delivery Lead to drive digital transformation of manufacturing systems.

You will lead MES, SCADA, Industry 4.0 initiatives, ensuring alignment with cGMP and data integrity while coordinating with IT and vendor teams. In this role, you’ll develop system requirements, design specs, test plans, and validation activities, and mentor staff through audits and inspections.

Qualifications

• Doctorate in Engineering, or Master’s with 2+ years manufacturing systems/automation experience, or Bachelor’s with 4+ years in the field.
• Experience in pharmaceutical/biotech processes, especially inspection or packaging operations.
• Strong organizational, project management and problem-solving abilities.
• Knowledge of data integrity and cybersecurity concepts.

Responsibilities

• Lead the digital transformation of manufacturing systems, including MES/SCADA and Industry 4.0 initiatives.
• Develop system requirements, design specifications, test plans, and validation documentation.
• Coordinate commissioning, qualification, validation, and change control activities.
• Train users and support audits/inspections, ensuring cGMP compliance.

Skills

Cross-functional leadership

Teamwork & communication

Regulated manufacturing experience

Problem solving

Adaptability

Lean/Operational Excellence

Education

Doctorate in Engineering

Master’s in Engineering + 2 yrs Manufacturing Systems/Automation

Bachelor’s in Engineering + 4 yrs Manufacturing Systems/Automation

Tools

Rockwell Automation

Cognex Machine Vision

Systech Guardian/Advisor/Sentri

Databases

GAMP/GMP documentation

Job description

Sr. Systems Engineer - Project Delivery Lead

Career Category Engineering Job Description 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. Amgen is advancing a broad and deep pipeline and portfolio of medicines to treat heart disease, obesity and obesity-related conditions, rare diseases, inflammatory conditions and cancer. 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.

What you will do

Let’s do this. Let’s change the world. In this vital role you will lead the digital transformation of manufacturing systems, driving innovation, compliance, and operational excellence through ground breaking automation and smart technologies. Serve as a subject matter expert in manufacturing systems and digital technologies. Lead the implementation and integration of MES, SCADA, Industry 4.0 solutions, and other manufacturing IT systems. Lead the development of budgetary cost estimates for the technology scope of capital projects Collaborate with multi-functional teams to define system requirements and ensure alignment with business needs. Develop system documentation, including user requirements, design specifications, and test plans. Troubleshoot system issues and coordinate resolution with IT and vendor support teams. Ensure system compliance with cGMP, data integrity, and cybersecurity requirements. Support system commissioning & qualification, validation and change control activities. Train users on system functionality and best practices. Participate in audits and inspections, providing system documentation and support. Stay informed on new technologies and digital trends in manufacturing. Promote a culture of digital innovation and operational excellence.

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The Associate Mfg Systems Engineer professional we seek is a technical individual contributor with these qualifications Basic Qualifications: Doctorate degree in Engineering Or Master’s degree in Engineering and 2 years of Manufacturing Systems/Automation experience Or Bachelor’s degree in Engineering and 4 years of Manufacturing Systems/Automation experience Preferred Qualifications: Advance degree in Computer, Electrical, Mechanical, Chemical Engineering, or Biomedical Engineering Knowledge and/or experience of pharmaceutical/biotech processes, especially in the areas of inspection or packaging operations Organizational, project management, and problem-solving capability Knowledge in Data Integrity and Cybersecurity Extensive understanding and background in programming, design, installation, validation, and lifecycle management of manufacturing process controls, automation, field instrumentation technologies Expertise in Databases Expertise in Rockwell software platform Expertise in Machine Vision (Cognex), preferred Direct experience with Systech Serialization projects including experience with Guardian, Advisor, Sentri, and other Systech ancillary devices. 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 Excellent verbal and written communication skills together with demonstrated ability to work in a team environment.

• Proven track record of leading and executing cross-functional projects.
• Strong teamwork, excellent interpersonal and communication skills.
• Direct experience with medical devices/combination products and associated manufacturing processes. Experience in working with third-party vendors and equipment suppliers. Ability to work in a highly regulated and ever-changing industry.
• Ability to learn and rapidly adapt to new requirements in a fast-moving environment.
• An Operational Excellence and Lean Transformation approach to work product – driving rapid results.

What you can expect of us

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.

Sponsorship

Sponsorship Sponsorship for this role is not guaranteed. As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of 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. We make all employment decisions without regard to race, color, religion, sex or any other characteristic protected by applicable law. We provide reasonable accommodations to applicants and employees with disabilities, consistent with legal requirements. Please contact us to request accommodation.

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.

Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology. Amgen focuses on areas of high unmet medical need and leverages its biologics manufacturing expertise to strive for solutions that improve health outcomes and dramatically improve people’s lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world’s leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential. For more information, visit www.amgen.com and follow us on www.twitter.com/amgen