Senior Manufacturing Systems Engineer Manufacturing Systems and Integrated Technologies

Lets do this. Lets change the world. In this vital role, you will be a part of our Clinical and Commercial Manufacturing Operations Technology team, driving the operation, refinement, and integration of cutting-edge manufacturing applications. This role is an excellent opportunity to gain an understanding of Amgens key manufacturing systems, working with various MCS (Manufacturing and Clinical Supply) business partners to ensure products to patients by managing and supporting key computerized systems such as MES (Manufacturing Execution System), Clinical Label Printing and Packaging, PI Data Historian, Instrument Data Acquisition (IDA) and other integrated systems.

As a member of our team, you'll be the driving force behind our mission to deliver high-quality products efficiently and effectively. This role will be responsible for managing the MES platform and associated integrations for the ATO site. In addition to supporting key manufacturing operations, you will work closely with the Global Instrument Data Acquisition (IDA) team to drive a Global MES Standardization effort across all Amgen manufacturing locations. This includes ensuring seamless integration of instrument data, implementing standardized MES processes and protocols, and collaborating with global stakeholders to align best practices and compliance requirements. Your efforts will be critical in optimizing manufacturing systems, enhancing data integrity, and promoting consistency and efficiency across Amgens worldwide network.

You'll collaborate closely with cross-functional teams, site business leads and plant leads that include Manufacturing, Supply Chain, Quality, MCS Engineering, Enterprise Architects, and MES/IDA Global Teams to ensure seamless implementation and optimization of MES, PI Historian Systems, and support partnering with MCS automation/engineering teams for GLAM project support.

The role will be part of the Site Operations Technology team which is responsible for delivering systems in support of Clinical and Commercial Manufacturing, working in a client facing ATO site- focused approach., * Support key TCT manufacturing systems by driving operational stability and continuous improvements across Building 7, B20, B23, and the ATO site.

• Manage key system integrations, both existing and new, to streamline manufacturing operations.
• Champion business process improvements and support strategic digital initiatives by leveraging established platforms, city plan technology, and artificial intelligence applications.
• Provide on-call support, including after-hours escalations and troubleshooting for operations technology application issues, aligned with 24x7 manufacturing requirements at the ATO site.
• Lead major incident and problem investigations, including root cause analysis, deviation investigations, corrective actions, and 5-why analysis.
• Ensure compliance by maintaining and updating inspection readiness for critical applications, including inspection playbooks, periodic assessments for data integrity, security, and system compliance, and SDLC validation and testing.
• Support regulatory inspections by providing data, delivering presentations on site systems and technology processes, and collaborating with subject matter experts as needed.
• Lead initiatives to introduce Industry 4.0 technologies to improve manufacturing efficiency and capacity.
• Lead and train team members to support operational excellence and develop multi-system competencies.
• Support and lead CMDB updates and system health, ensuring accurate and up-to-date configuration data in partnership with service owners and managers.
• Support the assessment of impactful changes during weekly ATO Change Advisory Board (CAB) meetings.
• Support Amgens cyber resiliency efforts, including Sentinels and ECR Network initiatives.
• Provide on-site, client-facing support at the ATO site up to five days per week, based on business needs.

Doctorate degree

OR

Masters degree and 2 years of Information Systems/Systems Engineering experience

OR

Bachelors degree and 4 years of Information Systems/Systems Engineering experience

OR

Associates degree and 8 years of Information Systems/Systems Engineering experience

OR

High school diploma / GED and 10 years of Information Systems/Systems Engineering experience, * BS/MS degree in Information Systems, Computer Science, Engineering, or the Life Sciences.

• 5+ years experience in the biotech/pharmaceutical industry and working with GxP computer systems in a regulated environment.
• Experience with Amgen Technology Systems support and validation.
• Database skills (queries, stored procedures, reports).
• Experience with CDOCS, Application Lifecycle Management (ALM).
• Strong history of analytical and troubleshooting skills.
• Experience with ISM/AmgenNow is preferred.
• Work experience within biotechnology, pharmaceutical, or healthcare.
• Strong leadership/consultative, collaboration, project management, service delivery, and process improvement skills to facilitate alignment across multiple stakeholder groups.
• Strong experience in systems analysis. Ability to work with business clients to understand their business processes, manage scope of work/expectations, and suggest/recommend IS solutions.
• Experience leading the IS change control process and building, validating, and supporting GxP systems.
• Strong written, presentation, and verbal communication skills and technical expertise to be able to communicate effectively with business and technology partners.
• Organization, with proven ability to quickly learn new concepts and technologies and prioritize outcomes.
• Experience in technical writing and performing root cause analysis of incidents/deviations and handling CAPA.

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 where possible. Refer to the Work Location Type in the job posting to see if this applies

At Amgen, if you feel like youre part of something bigger, its because you are. Our shared missionto serve patients living with serious illnessesdrives all that we do. Since 1980, weve helped pioneer the world of biotech in our fight against the worlds toughest diseases. With our focus on four therapeutic areas Oncology, Inflammation, General Medicine, and Rare Disease we reach millions of patients each year. Amgen is advancing a broad and deep pipeline of medicines to treat cancer, heart disease, inflammatory conditions, rare diseases, and obesity and obesity-related conditions. As a member of the Amgen team, youll 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, youll 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., We are all different, yet we have this in common: our mission to serve patients. This sense of shared purpose is key to our becoming one of the world's leading biotechnology companies. It guides us as we continue to launch new medicines and reach millions of patients worldwide. We live the mission. We win together. We thrive on continual challenge. Our team of 22,000+ scientists and professionals worldwide bring distinct perspectives and experiences to all we do. We leverage our global talent to achieve together-to research, manufacture and deliver ever-better products and greater depth to our mission. At Amgen, there is a strong correlation between our high level of diversity and performance. Because addressing issues with a wider range of perspectives and approaches leads to more creative problem-solving. Together, we're transforming the promise of science and biotechnology into therapies that have the power to restore health. Connect with us to explore how you can Win, Live, and Thrive at Amgen.