Technology Compliance Specialist (GxP Manufacturing)
Career Category
Information SystemsJob Description
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.
- 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.
Basic Qualifications and Experience
- Any degree with 8-13 years of experience in Life Sciences, Biotechnology, Pharmacology, Information Systems, Computer System Validation, Quality, or Technology Compliance.
Functional Skills
Must-Have Skills
- 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.
Good-to-Have Skills
- 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 degree of initiative and self-motivation.
- Ability to manage multiple priorities successfully.
- Team-oriented, with a focus on achieving team goals.
- Strong presentation and public speaking skills.
Shift Information
This position may require working a later shift and may be assigned to a second or third shift schedule. Candidates must be willing and able to work during evening or night shifts, as required based on business needs.
Equal Opportunity Statement
Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.
We will ensure that individuals with disabilities are provided with reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment.
Ready to Apply for the Job?
We highly recommend utilizing Workday’s robust Career Profile feature to complete the application process. A link to update your profile is available when you click Apply. You can then complete your Workday profile in minutes with the “Upload My Experience” functionality to upload an updated copy of your resume, or you can simply edit the individual sections of your Career Profile.
Please note that you should be in your current position for at least 18 months before applying to internal positions. Staff must notify their current manager if invited for an interview. In addition, Staff are ineligible to apply for open positions if their performance is currently being managed on a performance improvement plan, or other locally utilized formal coaching document, or if their most recent performance rating was not a “Partially Meets Expectations” or higher. Please visit our Internal Transfer Guidelines for more detailed information.
GCF Level
GCF Level 05
Career Category
Information Systems
Position Type
Full time
.