STEM Smart IT

Location: Remote (Must be available to work Pacific Standard Time hours) Employment Type: Full-Time | Individual Contributor Position Overview We are seeking a highly experienced Computer Systems Validation (CSV) Engineer to support validation activities for regulated life sciences environments. The successful candidate will possess extensive hands-on experience with Veeva Vault validation and demonstrated capability in independently authoring and executing comprehensive validation deliverables. This position requires prior experience working with geographically distributed teams, particularly in the United States and United Kingdom, and the ability to operate effectively within Pacific Standard Time working hours. Key Responsibilities Lead and execute end-to-end Computer Systems Validation activities in accordance with GxP, 21 CFR Part 11, Annex 11, GAMP5, and applicable regulatory standards. Independently develop and maintain validation documentation including, but not limited to, Validation Plans, URS, FRS, Risk Assessments, RTM, IQ/OQ/PQ protocols, test scripts, deviation management, and Final Validation Reports. Perform validation activities for Veeva Vault applications , including enhancements, configurations, and system updates. Support release management processes, including impact assessments and validation readiness activities. Conduct Gap Analysis to identify compliance risks and recommend/implement remediation strategies. Ensure systems remain audit-ready and support internal and external regulatory inspections as required. Collaborate effectively with cross-functional stakeholders across US and UK teams, including Quality, IT, Business, and Compliance organizations. Required Qualifications Minimum 10 years of hands-on experience in Computer Systems Validation within the pharmaceutical, biotechnology, or life sciences industry. Mandatory experience in validating Veeva Vault platforms . Strong knowledge of GxP regulations, 21 CFR Part 11, Annex 11, and GAMP5 principles. Demonstrated ability to independently author and execute all validation lifecycle documentation without reliance on additional support. Proven track record as an individual contributor in a highly regulated environment. Prior experience working with US and/or UK cross-functional teams . Excellent written and verbal communication skills, with strong attention to detail and documentation quality. Preferred Qualifications Experience supporting Release Management initiatives. Experience conducting Gap Analysis and compliance remediation planning.