Senior Manufacturing Systems Engineer Manufacturing Systems and Integrated Technologies

Senior Manufacturing Systems Engineer Manufacturing Systems and Integrated Technologies 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 Amgen’s 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 Amgen’s 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. Responsibilities 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 Amgen’s 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. What we expect of you We are all different, yet we all use our unique contributions to serve patients. The professional we seek is an individual with these qualifications. Basic Qualifications Doctorate degree Masters degree and 2 years of Information Systems/Systems Engineering experience Bachelors degree and 4 years of Information Systems/Systems Engineering experience Associates degree and 8 years of Information Systems/Systems Engineering experience High school diploma / GED and 10 years of Information Systems/Systems Engineering experience Preferred Qualifications 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. 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 well 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 where possible. 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. #J-18808-Ljbffr Initial Therapeutics, Inc.