Technology Compliance Specialist (GxP Manufacturing)

Amgen Inc. (IR); Hyderabad; Hybrid; INR 1,200,000 - 1,800,000; Full time

Job summary

Amgen Inc. seeks a Technology Compliance Specialist to support GxP compliance, validation, and data integrity for computerized systems across the ABR site. You will coordinate validation lifecycle activities and maintain inspection-readiness documentation with cross-functional teams.

The role emphasizes governance, risk assessment, and standardized documentation in collaboration with global technology teams, site leadership, and Quality groups.

Qualifications

• 8–13 years of experience in Life Sciences, Biotechnology, Pharmacology, Information Systems, or Technology Compliance.
• Knowledge of GxP compliance and data integrity requirements (21 CFR Part 11, EU Annex 11).
• Experience with computer system validation and risk-based approaches.

Responsibilities

• Provide guidance on technology compliance and validation activities across sites.
• Support validation lifecycle documentation, periodic reviews, and evidence collection.
• Monitor and follow up on open actions, exceptions, and deliverables.
• Prepare and maintain inspection-readiness materials and compliance dashboards.
• Collaborate with global and site teams to standardize processes and documentation.

Skills

GxP compliance

21 CFR Part 11

Data integrity

Regulatory alignment

Technical writing

Stakeholder management

Risk assessment

Validation lifecycle

Education

Life Sciences degree

Computer System Validation background

Tools

Jira Align

Documentation tools

Job description

Career Category Information Systems

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.

Career Category Information Systems

GCF Level GCF Level 05 Career Category Information Systems Position Type Full time . Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology. Amgen focuses on areas of high unmet medical need and leverages its biologics manufacturing expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential. For more information, visit www.amgen.com and follow us on www.twitter.com/amgen