Career CategoryManufacturing
Job DescriptionManufacturing Execution Systems SpecialistWhat you will doLet'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 youWe are all different, yet we all use our unique contributions to serve patients. The dynamic professional we seek is an individual with these 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 requirements specifications into MES solutions
- Ability to manage multiple priorities in a fast-paced environment
What you can expect from usAs 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.
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 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. Refer to the Work Location Type in the job posting to see if this applies.
Apply now and make a lasting impact with the Amgen team.
careers.amgen.comIn any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information.
Application deadline
Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position.
Sponsorship
Sponsorship for this role is not guaranteed.
