Validation Engineer I

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 G xP platform supporting the automation of data for 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.

The role also leverages domain and business process expertise to drive ongoing improvements to validation and meets our regulatory and validation procedures. This role involves working closely with developers and business analysts to ensure that the technical requirements for upcoming development are thoroughly elaborated and validated .

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.

Identify opportunities to enhance testing efficiency and minimize manual efforts.

Evaluate and adopt tools and technologies to improve automation capabilities.

Keep validation documentation updated and aligned with GMP standards.

Ensure strict adherence to change management processes for validated systems.

Stay informed on industry trends, emerging technologies, and regulatory updates relevant to GMP and data automation.

Provide expert technical support in validation to optimize quality, efficiency, and cost for developing, troubleshooting, and improving new and existing applications and platforms .

Basic Qualifications and Experience:

Masters degree and 1 to 3 years of Life Science/Biotechnology/Pharmacology/Information Systems experience OR

Bachelors 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 and a passion for tackling complex challenges in drug discovery with technology

Experience with Agile software development methodologies (Scrum)

Excellent communication skills and the ability to interface with senior leadership with confidence and clarity

Experience in writing requirements for development of modern web application

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

Familiarity with low-code, no-code test automation software

Technical thought leadership

Able to communicate technical or complex subject matters in business terms

Jira Align experience

Knowledge of DevOps, Continuous Integration, and Continuous Delivery methodology

Professional Certifications (please mention if the certification is preferred or mandatory for the role):

SAFe for Teams certification (preferred)

Soft Skills:

Able to work under minimal supervision

Skilled in providing oversight and mentoring team members. Demonstrated ability in effectively delegat ing work

Excellent analytical and gap/fit 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