Technology Compliance Specialist (GxP Manufacturing)

Career Category

Information Systems

Description

Amgen harnesses the best of biology and technology to fight the world’s toughest diseases and make people’s lives easier, fuller, and longer. We discover, develop, manufacture, and deliver innovative medicines to help millions of patients. Amgen helped establish the biotechnology industry more than 40 years ago and remains on the cutting edge of innovation, using technology and human genetic data to push beyond what is known today.

About the Role

The Technology Compliance Specialist is part of the Amgen Breda site Technology team and supports Technology compliance, validation, periodic review, and data integrity activities for GxP computerized systems at the ABR site.

The role provides additional technology compliance support required by volume-driven growth, new technology deployments through DMI and site modernization programs, and the expansion of continuous improvement solutions, including the additional effort needed to administer, track, and maintain compliance-related ServiceNow records and workflows.

This role is focused on technology compliance operations and administrative oversight activities that can be performed remotely in partnership with manufacturing, quality, validation, system owners, Site Technology Compliance Leads and global technology teams. The role provides centralized support, coordination, documentation, tracking, analysis, and governance support to help maintain systems in a validated state of operation.

The individual will support the planning, monitoring, documentation, and reporting of compliance and validation lifecycle activities, including periodic reviews, data integrity assessments, inspection-readiness documentation, deviation support, and compliance metrics. The role will collaborate with Site Technology Compliance Leads, validation stakeholders, quality, system owners, and technology teams to promote consistent processes, quality deliverables, and alignment with Amgen standards and regulatory expectations.

Roles & Responsibilities

• Provide guidance for site Technology team members and support them in technology compliance and validation activities.