Senior Manufacturing Systems Engineer: Automation

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!

As a Senior Manufacturing Systems Engineer, you will provide automation technical leadership to a group of automation engineers who are responsible for building and maintaining various automation systems and platforms that support the GMP Drug Substance Plant Operations.

In this vital role as a member of the Facilities & Engineering (F&E) Automation team you will work hand in hand with the capital project team to deliver robust automation systems to operate the new plant. This includes complex and challenging system automation initiatives that require solid understanding of various automation platforms, integration between different platforms, analytical problem-solving techniques, project management, lifecycle management and Operational Excellence.

• Site construction, start-up, and operational readiness:

• Develop and maintain the building automation system on Siemens Desigo CC.

• Work with process subject matter experts (SMEs) to understand key process requirements and transform them into digital automated solutions.

• Collaborate with business partners to understand how utility and building equipment systems automation can improve workflow and productivity. Synthesize requirements from clients, customers or end-users to develop the best automation solutions.

• Provide clear documentation for delivered solutions and processes; work closely with QA partners while supporting computerized systems validation processes in a GxP environment. Maintain Data Integrity Assessments with the current Amgen and Industry standards.

• Build the business processes to support the project scope in alignment with project timelines. Develop detailed specification and engineering policies and procedures that affect multiple organizational units.

• Support commissioning and qualification efforts including Automation Installation Verification/Automation Check Out (IV/ACO) in a fast-paced environment.

• On-going operations:

• Lead and support functional area projects focused on improving process equipment/utilities/facilities as well as large/sophisticated capital projects to integrate new drug substance manufacturing technologies into the facility.

• Lead/support technical root cause analysis, incident investigations, and troubleshooting on utilities and building automation controls

• Lead and support new product introductions (NPI) or new technology introductions by performing automation engineering assessments, implementing automation system configuration changes and supporting engineering and process qualification runs as applicable.

• Manage Day-to-day Operational Support including: 24 x 7 Onsite/On Call Operational Support, Troubleshooting Support to Plant and Mfg. Operations, Utility systems, Utility and BAS Administration, Preventative and corrective maintenance, and Automation System spare parts management

• Be constantly curious and feed your passion and interests in groundbreaking technology. Use your given time to look for new and innovative ways to do business differently, better, and more cost effectively.

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The automation professional we seek is an engineer with these qualifications.

Basic Qualifications:

• High School Diploma / GED and 10 years of Engineering experience OR

• Associate’s Degree and 8 years of Engineering experience OR

• Bachelor’s Degree and 4 years of Engineering experience OR

• Master’s Degree and 2 years of Engineering experience OR

• Doctorate Degree

Preferred Qualifications:

• Degree in Electrical Engineering or Computer Science, Chemical Engineering or Biotech Engineering.

• Direct knowledge of BMS design, experience in building control engineering and troubleshooting with GMP biopharmaceutical production facility and utility equipment/systems automation and integrating various OEM automation software.

• Extensive understanding and background in programming, design, installation and lifecycle management of building automation controls, PLC and field device/instrumentation technologies.

• Experience with Siemens Building Automation system, Rockwell industrial automation hardware and systems, ability to perform advanced troubleshooting activities with Amgen IS, System Integration using OPC, Foundation Fieldbus, Profibus, and DeviceNet technologies.

• Ability to interpret and apply GAMPs and GMPs and familiarity with documentation in a highly regulated environment with requirements such as 21 CFR Part 11, ASTM 2500, S88, and S95.

• Experience in Capital Project Lifecycle Management: Conceptual Design, Scope and cost estimate development, business case development, detailed design, engineering and validation documentation and project execution.

• Demonstrated experience with continuous improvements resulting in enhanced safety, system reliability, and productivity (e.g., cycle times, and reduced plant utilities usage etc.)

• The ideal individual must be a self-directed team player ready to mentor and develop engineering staff and embrace a team-based culture that relies on collaboration for effective decision-making.

• Strong leadership, technical writing, and communication/presentation skills.

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

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.