Senior Manufacturing Systems Engineer, IS/Automation

BioSpace

Holly Springs (NC)

On-site

USD 120,000 - 180,000

Full time

2 days ago

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Benefits offered by this job

Retirement and Savings Plan

Stock-based long-term incentives

Flexible work models

Job summary

Amgen seeks a Principal Manufacturing Systems Engineer to join its advanced drug-substance manufacturing plant. You will lead IS/Automation projects, align with corporate standards, and enable industry 4.0 capabilities across the facility.

The role emphasizes cross-functional leadership, validation, cyber security, and continuous improvement. Amgen offers a broad rewards package and growth opportunities as you help deliver innovative medicines.

Qualifications

Doctorate/master/bachelor/associate/high school with relevant IS automation experience.
Experience with manufacturing automation and information systems in pharma/biotech environments is preferred.
Familiarity with GAMP, ISA-S88/S95, 21 CFR Part 11, validation and change control.
Strong cross-functional collaboration, communication, and leadership skills.
Hands-on coding experience in PCS and MES environments; ability to lead multi-functional teams.

Responsibilities

Own successful delivery of varied IS/Automation project portfolios with planning, resources, risk, and financial management.
Coordinate cross-system assessments, feasibility analyses, scope projects, and propose optimal solutions.
Translate business needs into functional design and ensure alignment with corporate standards.
Communicate risks and solutions to stakeholders at multiple levels within the organization.
Lead and influence multi-functional teams and manage vendor relationships.