Manufacturing Systems Engineer

Amgen • Thousand Oaks, CA

1d • Onsite

About The Position

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 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. 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.

Requirements

• Master’s degree OR Bachelor’s degree and 2 years of Information Systems/Manufacturing Systems Engineering experience OR Associate’s degree and 6 years of Information Systems/Manufacturing Systems Engineering experience OR High school diploma / GED and 8 years of Information Systems/Manufacturing Systems Engineering experience

Nice To Haves

• 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.

Responsibilities

• 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 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.

Benefits

• 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

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Number of Employees: 5,001-10,000 employees