Mfg Technologies Sr Mgr - Holly Springs, NC
About The Position
In this vital role, you will manage a defined set of Manufacturing Execution Systems (MES) objects, such as GMBRs (electronic batch records) and equipment management objects (ESPs, state diagrams), that are utilized across all applicable manufacturing sites. Specific responsibilities include but are not limited to: Collaborate, communicate be accountable for leading forums with multi-functional areas and make the appropriate decisions for the best interest of Amgen. May include ownership of global MES SOPs in addition of provide input and review of related global training materials. Strategize with Technology team on application roadmap and accommodating new offered functionality. Own system related controlled documents such as data integrity assessment report, operational SOPs, and training content. Lead and approve validation documents and records such as validation plan, OQ protocol, configuration specifications, requirements specs, validation summary (backup) report, test scripts, test sets, and test runs mostly for MES but also some for ERP.
Requirements
- Doctorate degree and 2 years of Manufacturing support experience OR Master’s degree and 4 years of Manufacturing support experience OR Bachelor’s degree and 6 years of Manufacturing support experience Or Associate’s degree and 10 years of Manufacturing support experience Or High School diploma / GED and 12 years of Manufacturing support experience
- Proficient communication skills in English.
Nice To Haves
- Academic background in Life Science, and/or Engineering.
- Leadership experience managing contractors and indirect reports.
- Background in Drug Substance, Finish Drug Product (FDP) and/or Drug Product.
- MES technology knowledge with experience modifying batch records.
- Experience with MBR design in Koerber’s PAS|X.
- MES system experience in biological manufacturing floor operations.
- Regulated environment work experience with cross-functional collaboration, working in teams.
Responsibilities
- Manage a defined set of Manufacturing Execution Systems (MES) objects, such as GMBRs (electronic batch records) and equipment management objects (ESPs, state diagrams), that are utilized across all applicable manufacturing sites.
- Collaborate, communicate be accountable for leading forums with multi-functional areas and make the appropriate decisions for the best interest of Amgen.
- Own system related controlled documents such as data integrity assessment report, operational SOPs, and training content.
- Lead and approve validation documents and records such as validation plan, OQ protocol, configuration specifications, requirements specs, validation summary (backup) report, test scripts, test sets, and test runs mostly for MES but also some for ERP.
Benefits
- A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental & vision coverage, life and disability insurance
- 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, including remote and hybrid work arrangements, where possible
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What This Job Offers
Job Type
Full-time
Career Level
Senior
Education Level
Ph.D. or professional degree
