Manufacturing Execution Systems Specialist

Amgen•Thousand Oaks, CA

22h

About The Position

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. Amgen is advancing a broad and deep pipeline of medicines to treat cancer, heart disease, inflammatory conditions, rare diseases, and obesity-related conditions. 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. Manufacturing Execution Systems Specialist What you will do Let’s do this. Let’s change the world. In this vital role within the B20 Drug Product manufacturing organization, you will serve as a Manufacturing Execution System (MES) Subject Matter Expert (SME) supporting manufacturing operations, lifecycle management, and new product introductions (NPIs), at a Drug Product (DP) Manufacturing facility. This role is focused on design, development, validation, and continuous improvement of Electronic Batch Records (EBRs) and MES capabilities to enable reliable, compliant, and efficient manufacturing processes. You will act as a technical MES leader, partnering cross-functionally with Manufacturing, Process Development, Supply Chain, Quality, and Engineering to ensure MES solutions align with business processes and regulatory requirements. This position will also contribute to network-wide MES standardization, digital transformation, and continuous improvement initiatives across the site and network, with a strong emphasis on DP manufacturing processes (e.g., formulation, filling, inspection, and packaging).

Requirements

Doctorate degree OR Master’s degree and 2 years of Manufacturing Execution Systems experience OR Bachelor’s degree and 4 years of Manufacturing Execution Systems experience OR Associate’s degree and 8 years of Manufacturing Execution Systems experience OR High school diploma / GED and 10 years of Manufacturing Execution Systems experience

Nice To Haves

Hands-on experience with Körber PAS-X (EBR design and development)
Experience with MES validation and lifecycle management in a GMP environment
Strong technical writing and communication skills
Strong familiarity with Drug Product manufacturing processes (formulation, filling, inspection, packaging)
Experience with system integrations (SAP, PI, DeltaV, Rockwell, Kepware)
Familiarity with quality systems (change control, deviations, CAPA, validation)
Strong troubleshooting and analytical problem-solving skills
Experience supporting NPIs from an MES perspective
Ability to translate manufacturing processes / user requirements specifications into MES solutions
Ability to manage multiple priorities in a fast-paced environment

Responsibilities

Design, develop, and maintain DP Manufacturing Electronic Batch Records (EBRs) using Körber PAS-X
Translate DP manufacturing processes / user requirement specifications into compliant MES templates, recipes, and workflows
Ensure EBRs and data reporting out of MES are robust, efficient, and aligned with GMP requirements
Support validation activities for MES / EBRs including testing and defect resolution
Provide day-to-day MES support to manufacturing operations, including troubleshooting and on-call support
Partner with NPI leads to enable MES readiness for New Product Introductions
Support deployment of new MES capabilities and system integrations (SAP, PI, DeltaV, Rockwell, Kepware)
Identify and implement improvements to MES design, usability, and performance
Contribute to MES standardization and best practices across the site and network
Support change control activities ensuring compliance with GMP procedures
Collaborate cross-functionally and communicate MES-related updates effectively

Benefits

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.
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.

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