Validation Lead

Role Name: Validation Lead

Department Name: Enterprise Engineering and Analytics (EEA)

Role GCF: 4

Job Family: Software Development Engineer-Test I I

Hiring Manager Name: Asha Rani

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

Role Description:

We seek a skilled Validation Lead to oversee and manage validation activities for data platforms and solutions . As a key contributor, you will collaborate closely with cross-functional teams to ensure that the data and analytics products follow the required validation processes, documentation, and comply with Amgen’s standard operating procedures, policies, and guidelines . Your expertise will be instrumental in ensuring quality and adherence to required standards so that the engineering teams can build and deploy products that are compliant .

Roles & Responsibilities:

Plan, coordinate, and lead the execution of 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.

Stay updated on relevant changes to Amgen’s SOPs and ensure validation practices are aligned with evolving standards.