Technology Compliance Specialist (GxP Manufacturing)

Job title: Technology Compliance Specialist (GxP Manufacturing)

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.

What You'll Do

• Provide guidance for site Technology team members and support them in technology compliance and validation activities.
• Support computer system validation activities, including validation lifecycle documentation, periodic reviews, data integrity assessments, compliance tracking, and inspection-readiness support.
• Monitor schedule adherence for GxP periodic review and data integrity activities, including follow-up on open actions, exceptions, and deliverables.
• Partner with Site Technology Compliance Lead, Validation Leads, Quality, System Owners, and Technology teams to review exceptions, support mitigation planning, and ensure alignment with Amgen standards.
• Support compliance documentation activities related to computer systems, including review coordination, evidence collection, document quality checks, and maintenance of controlled documentation.
• Assist with investigations, deviations, data integrity risks, and compliance events by gathering technical information, documenting findings, and preparing supporting artifacts.
• Provide technology compliance input for system changes, risk assessments, periodic reviews, and validation sustainment activities.
• Support preparation and maintenance of inspection-readiness materials, compliance dashboards, action trackers, and evidence repositories.
• Collaborate with global and site teams, including Site Technology Compliance Leads, to promote consistent Technology compliance processes and standardized documentation practices.
• Ensure compliance deliverables are completed with appropriate quality, traceability, and alignment to applicable regulatory requirements and internal procedures.
• Identify opportunities to improve compliance operations, documentation quality, reporting, and process efficiency.
• Maintain high-quality documentation for GxP technology systems and related compliance activities.

What We're Looking For

• Any degree with 8–13 years of experience in Life Sciences, Biotechnology, Pharmacology, Information Systems, Computer System Validation, Quality, or Technology Compliance.
• Strong knowledge of GxP computer system compliance, including 21 CFR Part 11, EU Annex 11, data integrity, computer system validation, and validation lifecycle expectations.
• Knowledge and experience in applying risk-based approaches to computer system validation and technology compliance.
• Strong technical writing, documentation review, and compliance documentation skills.
• Excellent problem-solving, communication, and stakeholder-management skills, with the ability to work effectively with cross-functional teams.
• Nice to Have: Understanding scientific software systems, technology governance, application sustainment, and infrastructure concepts.
• Ability to communicate technical and technology compliance topics in clear business terms.
• Experience with Jira Align or similar work-management tools.
• Knowledge of network security concepts, protocols, and tools such as IPSEC, SSL, IDS/IPS, and firewalls.
• Experience supporting inspection readiness, audit preparation, compliance metrics, and evidence management.
• Professional Certifications: SAFe for Teams certification preferred.
• Soft Skills: Able to work under minimal supervision; skilled in providing oversight, mentoring team members, and effectively delegating work; excellent analytical and gap-assessment skills; strong verbal and written communication skills; ability to work effectively with global, virtual teams; high initiative and self-motivation; ability to manage multiple priorities; team-oriented; strong presentation and public speaking skills.

Nice to Have

• Understanding scientific software systems, technology governance, application sustainment, and infrastructure concepts.
• Ability to communicate technical and technology compliance topics in clear business terms.
• Experience with Jira Align or similar work-management tools.
• Knowledge of network security concepts, protocols, and tools such as IPSEC, SSL, IDS/IPS, and firewalls.
• Experience supporting inspection readiness, audit preparation, compliance metrics, and evidence management.