Validation Lead - Data Platforms and Solutions

About the role

Amgen is looking for a Validation Lead within its Enterprise Engineering and Analytics (EEA) department to oversee and manage validation activities for data platforms and solutions. You will work closely with cross-functional teams so that data and analytics products follow the required validation processes, documentation and compliance with Amgen's standard operating procedures, policies and guidelines.

Key responsibilities

• Plan, coordinate and lead validation activities, including qualification and validation of data products and software applications.
• Develop, review and approve validation documentation such as Validation Plans, Validation Protocols (IQ/OQ) and Validation Reports.
• Ensure validation strategies meet regulatory requirements and company standards.
• Write, review and approve Installation Qualification (IQ), Operational Qualification (OQ) and Computer System Validation documents.
• Keep up with changes to Amgen's SOPs and align validation practices with evolving standards.
• Work with quality assurance, system owners, business owners, RunOps, engineering and platform teams to meet project deadlines.
• Track validation progress with the product owner and scrum master, and document deviations, change control and non-conformance.
• Identify process improvements and stay current on new technologies and validation trends.

Required profile

• 2+ years of validation experience in a GMP-regulated environment (pharmaceutical, biotech, medical devices, etc.).
• 5+ to 9 years of overall testing experience, with 2+ years in validation (mandatory).
• Experience leading software validation projects.
• Bachelor's or Master's degree in computer science and engineering preferred; other engineering fields considered.

Required skills

• Proficiency in developing and executing validation protocols (IQ, OQ, PQ), reports and related documentation.
• Familiarity with computer system validation and software validation is a plus.
• Good-to-have: experience with automated and computer-controlled systems validation (21 CFR Part 11).
• Strong problem-solving, analytical, communication and teamwork skills, and ability to work with global, virtual teams.