Mfg Tecnologies Sr Mgr

Amgen•Holly Springs, NC

23h•$137,416 - $185,916

About The Position

The Manufacturing Technologies Senior Manager manages a defined set of Manufacturing Execution Systems (MES) objects, including electronic batch records (GMBRs) and equipment management objects such as ESPs and state diagrams, used across applicable manufacturing sites. The role collaborates with multifunctional teams, leads forums, and makes decisions in Amgen’s best interest. It may include ownership of global MES standard operating procedures and contribution to related training materials. The position partners with the Technology team on application roadmaps and new functionality, owns system-related controlled documents, and leads and approves validation documents and records, primarily for MES and also for some ERP systems.

Requirements

One of the following education and manufacturing support experience combinations: doctorate degree and 2 years; master’s degree and 4 years; bachelor’s degree and 6 years; associate’s degree and 10 years; or high school diploma/GED and 12 years.

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 and experience modifying batch records.
Proficient communication skills in English.
Experience with MBR design in Koerber’s PAS|X.
MES system experience in biological manufacturing floor operations.
Work experience in a regulated environment with cross-functional collaboration and teamwork.

Responsibilities

Manage a defined set of MES objects, including GMBRs (electronic batch records) and equipment management objects such as ESPs and state diagrams.
Collaborate with multifunctional areas, lead forums, communicate, and make appropriate decisions in Amgen’s best interest.
Own global MES SOPs where applicable and provide input on and review related global training materials.
Strategize with the Technology team on the application roadmap and accommodate newly offered functionality.
Own system-related controlled documents, including data integrity assessment reports, operational SOPs, and training content.
Lead and approve validation documents and records, including validation plans, OQ protocols, configuration specifications, requirements specifications, validation summary (backup) reports, test scripts, test sets, and test runs, primarily for MES and also for some ERP.

Benefits

Health and welfare plans for staff and eligible dependents.
Financial plans with opportunities to save toward retirement or other goals.
Work/life balance and career development opportunities.
Retirement and Savings Plan with generous company contributions.
Group medical, dental, and vision coverage.
Life and disability insurance.
Discretionary annual bonus program, or a sales-based incentive plan for field sales representatives.
Stock-based long-term incentives.
Award-winning time-off plans.
Flexible work models, including remote and hybrid arrangements where possible.