Validation Engineer-Clinical Data Hub

*What you will do*

In this vital role You will play a key role in a content automation initiative which will modernize and digitize the regulatory submission process, positioning Amgen as a leader in regulatory innovation. The initiative demonstrates 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 Validation Engineer to work on a GxP platform supporting the Regulatory Submission system and Clinical Data Hub platform. 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 platform. This position combines technical expertise, validation experience, and a strong understanding of GXP 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.
• Find 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 GxP standards.
• Ensure strict alignment to organizational change processes for validated systems.
• Stay informed on industry trends, emerging technologies, and regulatory updates relevant to GxP.
• Provide expert technical support in validation to optimize quality, efficiency, and cost for developing, troubleshooting, and improving new and existing applications and platforms.

*What we expect of you*

We are all different, yet we all use our unique contributions to serve patients.

*Basic Qualifications and Experience:*

• Master's degree / Bachelor's degree and 5 to 9 years.

*Functional Skills:*

Must-Have Skills:

• Excellent problem-solving skills and a passion for tackling complex challenges in Clinical Development with technology
• Experience with Agile software development methodologies
• Proficiency in automation tools, data systems, and validation software.
• Excellent communication skills and the ability to interface with senior leadership with confidence and clarity
• Excellent collaboration, communication, must be flexible and able to manage multiple activities and priorities with minimal direction in a rapidly changing and demanding environment.
• Experience in writing requirements for development of modern web application
• Strong understanding of GAMP 5 guidelines, 21 CFR Part 11, and Annex 11.
• Have strong business acumen. Can demonstrate a deep understanding of pharma industry regulations and its compliance requirements

*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
• Experience in the software development lifecycle of GxP Systems.
• Technical thought leadership
• Able to communicate technical or complex subject matters in business terms
• Knowledge of DevOps, Continuous Integration, and Continuous Delivery methodology
• Strong analytical/critical-thinking and decision-making abilities.
• Ability to work effectively in a fast-paced, dynamic environment.
• Established business partnerships and IS governance practices involving senior business stakeholders
• Broad working knowledge of key IS domains and layers

*Professional Certifications:*

• 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 delegating 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

*Shift Information:*

• This position requires you to work a later shift and may be assigned a second or third shift schedule. Candidates must be willing and able to work during evening or night shifts, as required based on business requirements.