Technical/Functional Skills * Knowledgeable in 21 CFR Part 11, Annex 11, and GAMP 5 * Updates validation procedures, including change control, training, and audits, to ensure the maintenance of system validation. * Writes and reviews technical validation documents (e.g., validation plan, URS, FRS, Risk Assessment, Traceability Matrix, IQ/OQ/PQ/OPQ protocol, report, etc.) * Assists in system validation project activities (e.g., writing protocols, reviewing/approving test scripts, drafting validation reports, etc. Roles & Responsibilities * Conduct validation assessments for computer systems, software applications, and electronic records in compliance with healthcare regulatory requirements. * Develop and execute validation protocols, test scripts, and validation plans for computer systems used in the healthcare industry. * Collaborate with cross-functional teams, including IT, Quality Assurance, and Regulatory Affairs, to ensure alignment with validation requirements. * Perform risk assessments to identify potential vulnerabilities in computer systems and implement strategies for risk mitigation. * Provide expertise on validation best practices, industry standards, and regulatory expectations to internal teams. * Maintain accurate and up-to-date validation documentation, including validation reports, change control records, and standard operating procedures. * Participate in internal and external audits related to computer system validation and respond to audit findings as necessary. * Keep abreast of industry trends, regulatory updates, and technological advancements to enhance the validation process. Salary Range-$100,000-$135,000 a year #LI-KR1