Manufacturing Execution Systems Specialist
BioSpace, Thousand Oaks, CA, United States
Manufacturing Execution Systems Specialist
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 focuses on design, development, validation, and continuous improvement of Electronic Batch Records (EBRs) and MES capabilities to enable reliable, compliant, and efficient manufacturing processes.
What You Will Do
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. The position also contributes to network‑wide MES standardization, digital transformation, and continuous improvement initiatives across the site and network, with emphasis on DP manufacturing processes such as formulation, filling, inspection, and packaging.
Key Responsibilities
Design, develop, and maintain DP Manufacturing Electronic Batch Records (EBRs) using Krber 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 an individual with the following qualifications.
Basic Qualifications
Doctorate degree OR
Masters degree and 2 years of Manufacturing Execution Systems experience OR
Bachelors degree and 4 years of Manufacturing Execution Systems experience OR
Associates 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 Krber 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
What You Can Expect From Us
We support your professional and personal growth and well‑being with a competitive benefits package.
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
Application Process
Amgen does not have an application deadline for this position; applications will be accepted until sufficient candidates are received or a selected candidate is chosen.
Sponsorship for this role is not guaranteed.
Equal Opportunity Employment
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. Employees with disabilities will receive reasonable accommodations.
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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 focuses on design, development, validation, and continuous improvement of Electronic Batch Records (EBRs) and MES capabilities to enable reliable, compliant, and efficient manufacturing processes.
What You Will Do
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. The position also contributes to network‑wide MES standardization, digital transformation, and continuous improvement initiatives across the site and network, with emphasis on DP manufacturing processes such as formulation, filling, inspection, and packaging.
Key Responsibilities
Design, develop, and maintain DP Manufacturing Electronic Batch Records (EBRs) using Krber 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 an individual with the following qualifications.
Basic Qualifications
Doctorate degree OR
Masters degree and 2 years of Manufacturing Execution Systems experience OR
Bachelors degree and 4 years of Manufacturing Execution Systems experience OR
Associates 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 Krber 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
What You Can Expect From Us
We support your professional and personal growth and well‑being with a competitive benefits package.
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
Application Process
Amgen does not have an application deadline for this position; applications will be accepted until sufficient candidates are received or a selected candidate is chosen.
Sponsorship for this role is not guaranteed.
Equal Opportunity Employment
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. Employees with disabilities will receive reasonable accommodations.
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