Manufacturing Execution Systems Specialist
Amgen, Thousand Oaks, CA, United States
Manufacturing Execution Systems Specialist
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).
Key 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
What We Expect Of You
We are looking for someone with the following qualifications.
Basic Qualifications
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
Preferred Qualifications
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 requirement specifications into MES solutions
Ability to manage multiple priorities in a fast‑paced environment
What You Can Expect From Us
As we work to develop treatments that take care of others, we also 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.
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 health and welfare plans for staff and eligible dependents, financial plans with opportunities to save toward 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.
Equal‑Opportunity Employer
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.
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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).
Key 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
What We Expect Of You
We are looking for someone with the following qualifications.
Basic Qualifications
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
Preferred Qualifications
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 requirement specifications into MES solutions
Ability to manage multiple priorities in a fast‑paced environment
What You Can Expect From Us
As we work to develop treatments that take care of others, we also 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.
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 health and welfare plans for staff and eligible dependents, financial plans with opportunities to save toward 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.
Equal‑Opportunity Employer
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.
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