Mfg Technologies Sr Mgr - Holly Springs, NC

ATTENTION MILITARY AFFILIATED JOB SEEKERS:
Our organization works with partner companies to source qualified talent for their open roles. The following position is available to Veterans, Transitioning Military, National Guard and Reserve Members, Military Spouses, Wounded Warriors, and their Caregivers. Unless specifically stated otherwise, this role is "On-Site" at the location detailed in the job post.

Let’s do this. Let’s change the world. 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.

• 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.

• Doctorate degree and 2 years of Manufacturing support experience
• Master’s degree and 4 years of Manufacturing support experience
• Bachelor’s degree and 6 years of Manufacturing support experience
• Associate’s degree and 10 years of Manufacturing support experience
• High School diploma / GED and 12 years of Manufacturing support experience

• 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.
• Proficient communication skills in English.
• Experience with M  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.

As 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.

In addition to the Base Salary, Amgen offers a Total Rewards Plan, 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 & 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

Salary Range: USD -  USD

$100,000

City:
Holly Springs

State:
North Carolina

Job Code:
Pharmaceutical Pharmaceutical

Affiliate Sponsor:
Amgen