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Job Description
Structured overview of role & requirementsAbout This Role
Lead validation activities (IQ, OQ, PQ) for data platforms and software applications, ensuring compliance with Amgen’s SOPs and validation standards.
Implement and validate the ESKO artwork management system and its integration with systems like VEEVA, SAP, EDF, Workato, and Databricks, supporting analytics through Tableau.
Collaborate cross-functionally with quality assurance, engineering, platform, and business teams to complete validation tasks on schedule and maintain proper documentation including deviations and change control.
Minimum Requirements
Bachelor’s or Master’s degree in Supply Chain Technology, Business, Engineering, IT, or related field.
2 to 4 years of experience in software validation projects related to supply chain technology, engineering, or IT.
Proficiency in executing validation protocols (IQ, OQ, PQ) and associated documentation.
Work Experience Required: 2 to 4 years in relevant domain.
Ideal Candidate Profile
Experienced in validation of computer and software-controlled systems, ideally including knowledge of 21 CFR Part 11 compliance.
Strong analytical, problem-solving, and communication skills suited for cross-functional collaboration in global teams.
Comfortable with end-to-end software development lifecycle and driving validation efforts to meet regulatory and company standards.