Manufacturing Systems Engineer

Lets do this. Lets change the world. In this vital role, you will be 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. In addition to supporting key manufacturing operations, you will work closely on initiatives at the ATO site that enable automated data collection, support manufacturing processes with compliance and data integrity. This includes ensuring integration of instrument data, supporting standardized MES processes and protocols, and collaborating with site teams for reliable system and data collection. Your efforts will be important in support of optimization of manufacturing systems and being an advocate for cyber resilience.

You'll collaborate closely with cross-functional teams that include Manufacturing, Supply Chain, Quality, MCS Engineering, and MES/IDA Global Teams to support optimized implementation of MES, PI Historian Systems, while helping reliable and compliant system reliability with supporting validation, system upgrades, and continuous improvements.

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 (Trusted Core Technology) Manufacturing Systems, including operational and continuous improvements for the ATO site. This includes taking on or supporting an IT application owner role on GMP computerized systems.
• Support the site in inspection readiness, including partnering with various SMEs and IT application owners to update playbooks and representing the team in monthly computerized system forums.
• Support key system integrations, both existing and new, to streamline manufacturing operations.
• Support city plan technology and applications utilizing Artificial Intelligence (AI).
• Provide flexibility with on-call support, assisting in after-hours escalations and troubleshooting for Operations Technology application issues. The ATO site has 24x7 manufacturing operations; therefore, system changes, patching, and support in after-hours scenarios will be required.
• Support major incident and problem investigations, including root cause analysis, deviation investigations, corrective actions, and 5-why analysis.
• Ensure quality and compliance by maintaining and updating inspection readiness for critical applications, including inspection playbooks, periodic assessments for data integrity, security, and system compliance, and Software Development Lifecycle (SDLC) validation and testing.
• Support site-based projects by participating in small project teams, ensuring requirements are documented, assisting in technology assessments, and supporting adherence to long-term city planning standards.
• Support regulatory inspections by assisting with the generation of IRF documents and audit preparation activities with the ATO Site Technology team.
• Support initiatives to introduce Industry 4.0 technologies to increase manufacturing efficiency and capacity.
• Assist in CMDB (Configuration Management) updates and system health, supporting service owners and managers to ensure up-to-date information is captured.
• Support the assessment of impactful changes during weekly ATO CAB (Change Advisory Board) 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.

Masters degree, Bachelors degree and 2 years of Information Systems/Manufacturing Systems Engineering experience, Associates degree and 6 years of Information Systems/Manufacturing Systems Engineering experience, High school diploma / GED and 8 years of Information Systems/Manufacturing Systems Engineering experience, * Proactive and resourceful self-starter who takes ownership of tasks supporting key manufacturing systems issues, seeks out root causes, and continually learns by doing.

• Good communication skills, including the ability to share technical details with the management team, articulate issues, and provide potential solutions.
• Quick learner who demonstrates strong learning agility and rapidly gains proficiency in new systems, processes, and technologies to support reliable manufacturing operations.
• Experience with Amgen Technology Systems support and validation.
• Experience with cGMP and supporting audits.
• Experience with CDOCS and Application Lifecycle Management (ALM).
• Work experience within biotechnology, pharmaceutical, or healthcare organizations.
• Experience in technical writing for specifications, change control records, and incident support.
• Experience with small QC systems integration or automation systems is a plus.

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.