Manufacturing Execution Systems Specialist
Amgen
5 hours ago
On-site
Thousand Oaks, CA
Operations
Manufacturing Execution Systems (MES) Specialist (SME)
Responsibilities:
- Serve as a technical MES leader supporting manufacturing operations, lifecycle management, and New Product Introductions (NPIs).
- Design, develop, and maintain Drug Product (DP) Electronic Batch Records (EBRs) using Körber PAS-X.
- Translate DP manufacturing processes/user requirements into compliant MES templates, recipes, and workflows.
- Ensure EBRs and MES data reporting are robust, efficient, and aligned with GMP requirements.
- Support MES/EBR validation (testing and defect resolution).
- Provide day-to-day MES support (troubleshooting and on-call support).
- Enable MES readiness for NPIs; support deployment of new MES capabilities and integrations (SAP, PI, DeltaV, Rockwell, Kepware).
- Implement improvements to MES design/usability/performance; contribute to MES standardization and best practices.
- Support change control activities to ensure GMP compliance; communicate MES updates cross-functionally.
Basic Qualifications:
- Doctorate degree OR
- Master’s degree + 2 years MES experience OR
- Bachelor’s degree + 4 years MES experience OR
- Associate’s degree + 8 years MES experience OR
- High school diploma/GED + 10 years MES experience
Preferred Qualifications/Skills:
- Hands-on Körber PAS-X (EBR design/development)
- MES validation/lifecycle management in GMP; quality systems familiarity (change control, deviations, CAPA, validation)
- Technical writing/communication; troubleshooting/analytical problem-solving
- Knowledge of DP processes (formulation, filling, inspection, packaging)
- Experience with integrations (SAP, PI, DeltaV, Rockwell, Kepware)
- NPI experience from an MES perspective; translate user requirements into MES solutions
- Ability to manage multiple priorities in a fast-paced environment
Benefits (as stated):
- Comprehensive employee benefits package (retirement/savings, medical/dental/vision, life/disability, flexible spending)
- Discretionary annual bonus (or sales incentive for field sales)
- Stock-based long-term incentives, award-winning time-off, flexible work models where possible
Application Instructions:
- Apply at careers.amgen.com. No application deadline (applications accepted until sufficient candidates are received or a candidate is selected).
Responsibilities:
- Serve as a technical MES leader supporting manufacturing operations, lifecycle management, and New Product Introductions (NPIs).
- Design, develop, and maintain Drug Product (DP) Electronic Batch Records (EBRs) using Körber PAS-X.
- Translate DP manufacturing processes/user requirements into compliant MES templates, recipes, and workflows.
- Ensure EBRs and MES data reporting are robust, efficient, and aligned with GMP requirements.
- Support MES/EBR validation (testing and defect resolution).
- Provide day-to-day MES support (troubleshooting and on-call support).
- Enable MES readiness for NPIs; support deployment of new MES capabilities and integrations (SAP, PI, DeltaV, Rockwell, Kepware).
- Implement improvements to MES design/usability/performance; contribute to MES standardization and best practices.
- Support change control activities to ensure GMP compliance; communicate MES updates cross-functionally.
Basic Qualifications:
- Doctorate degree OR
- Master’s degree + 2 years MES experience OR
- Bachelor’s degree + 4 years MES experience OR
- Associate’s degree + 8 years MES experience OR
- High school diploma/GED + 10 years MES experience
Preferred Qualifications/Skills:
- Hands-on Körber PAS-X (EBR design/development)
- MES validation/lifecycle management in GMP; quality systems familiarity (change control, deviations, CAPA, validation)
- Technical writing/communication; troubleshooting/analytical problem-solving
- Knowledge of DP processes (formulation, filling, inspection, packaging)
- Experience with integrations (SAP, PI, DeltaV, Rockwell, Kepware)
- NPI experience from an MES perspective; translate user requirements into MES solutions
- Ability to manage multiple priorities in a fast-paced environment
Benefits (as stated):
- Comprehensive employee benefits package (retirement/savings, medical/dental/vision, life/disability, flexible spending)
- Discretionary annual bonus (or sales incentive for field sales)
- Stock-based long-term incentives, award-winning time-off, flexible work models where possible
Application Instructions:
- Apply at careers.amgen.com. No application deadline (applications accepted until sufficient candidates are received or a candidate is selected).