Amgen AI Job Opening – Life Sciences & Biotech Apply Online
Job ID: R-206596
Job role: Validation Engineer – GenAI and Content Automation
Location: India – Hyderabad
About Amgen
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’s known today.
About the Role
You will play a key role in a regulatory submission content automation initiative which will modernize and digitize the regulatory submission process, positioning Amgen as a leader in regulatory innovation. The initiative leverages state-of-the-art technologies, including Generative AI, Structured Content Management, and integrated data to automate the creation, review, and approval of regulatory content.
Role Description:
We are seeking an experienced Validation Engineer to work on a GxP platform supporting the automation of regulatory filings. This role will be pivotal in ensuring compliance, efficiency, and innovation in the management of data validation processes. The successful candidate will work on a small team and
support continuous improvements and automation within the program. This position combines technical expertise, validation experience, and a strong understanding of regulatory requirements.Roles & Responsibilities:
- Develop comprehensive test plans and strategies based on project specifications and requirements.
- Perform manual and automated testing of software applications, including functional, regression, and performance testing.
- Document and report defects identified during testing and collaborate with development teams for resolution.
- Maintain detailed records of test plans, test cases, and test results to ensure traceability and compliance.
- Validate test scenarios against feature acceptance criteria and customer expectations.
- Ensure system compliance with regulatory requirements for data integrity, traceability, and reliability.
Basic Qualifications and Experience:
- Master’s degree and 1 to 3 years of Life Science/ Biotechnology/ Pharmacology/ Information Systems experience OR
- Bachelor’s degree and 3 to 5 years of Life Science/ Biotechnology/ Pharmacology/ Information Systems experience OR
- Diploma and 7 to 9 years of Life Science/Biotechnology/Pharmacology/Information Systems experience
Functional Skills:
Must-Have Skills:
- Excellent problem-solving skills
- Experience with Agile software development methodologies (Scrum)
- Excellent communication skills
- Strong understanding of GAMP 5 guidelines, 21 CFR Part 11, and Annex 11
- Proficiency in automation tools, data systems, and validation software
Good-to-Have Skills:
- Demonstrated expertise in a scientific domain area and related technology needs
- Understanding of scientific software systems strategy, governance, and infrastructure
- Knowledge of DevOps, Continuous Integration, and Continuous Delivery methodology
Professional Certifications:
SAFe for Teams certification (preferred)
Soft Skills:
- Able to work under minimal supervision
- Skilled in providing oversight and mentoring team members
- Excellent analytical and gap/fit assessment skills
- High degree of initiative and self-motivation
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. Please contact us to request an accommodation.
Keywords: Validation Engineer, GenAI, Content Automation, Amgen, Regulatory Submission, GxP Platform, Life Science, Biotechnology, Pharmacology, Information Systems, Agile, GAMP 5, 21 CFR Part 11, Annex 11, DevOps, Continuous Integration, Continuous Delivery, SAFe for Teams. Amgen AI Job Opening – Life Sciences & Biotech Apply Online
