Validation Lead

Lets do this. Lets change the world. In this vital 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 demonstrates pioneering technologies, including Generative AI, Structured Content Management, and integrated data to automate the creation, review, and approval of regulatory content.

We are seeking an experienced Validation Engineer to lead efforts on a GxP 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 oversee a small team and drive continuous improvements and automation within the program. This position combines technical expertise, team leadership, and a solid understanding of regulatory requirements. The role also brings to bear 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.

• Oversee and drive all validation activities related to the GMP platform, ensuring compliance with FDA, EMA, and other regulatory standards.
• Develop and implement validation strategies, including risk assessments, protocols (IQ/OQ/PQ), and validation reports.
• Ensure the system meets regulatory requirements for data integrity, traceability, and reliability.
• Lead a small team of validation specialists, providing guidance, training, and performance management.
• Foster collaboration within the team and across functional groups (e.g., QA, IT, Regulatory Affairs).
• Collaborate with multi-functional teams to implement solutions that automate data processes for regulatory submissions.
• Find opportunities for improving system efficiency and reducing manual effort.
• Evaluate and implement tools and technologies to enhance automation capabilities.
• Maintain up-to-date documentation of validation activities and ensure alignment with GMP standards.
• Ensure consistency to organizational change processes for validated systems.
• Know the latest industry trends, technologies, and regulatory updates related to GMP and data automation.
• Provide experienced technical support in validation to meet objectives of quality, output and cost in developing, trouble shooting, standardizing and improving new and existing equipment.

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

Basic Qualifications:

• Masters degree with 4 - 6 years of experience in Life Science/Biotechnology/Pharmacology/Information Systems experience OR
• Bachelors degree with 6 - 8 years of experience in Life Science/Biotechnology/Pharmacology/Information Systems experience OR
• Diploma with 10 - 12 years of experience in Life Science/Biotechnology/Pharmacology/Information Systems experience.

Preferred Qualifications:

• Excellent problem-solving skills and a passion for tackling complex challenges in drug discovery with technology.
• Experience with Agile software development methodologies (Scrum).
• Good communication skills and the ability to work with senior leadership with confidence and clarity.
• Experience in writing requirements for development of modern web application.
• Solid understanding of GAMP 5 guidelines, 21 CFR Part 11, and Annex 11.
• Proficiency in automation tools, data systems, and validation software.
• 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.

• 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.