This role involves developing and executing IT validation activities and documentation, including protocols, test plans, and change controls.
Responsibilities include authoring validation plans, verification reports, and decommissioning documentation to ensure compliance with internal SOPs and external regulations such as 21 CFR Part 11 and GxP.
It requires participating in investigations of validation deviations, implementing corrective actions, and supporting the entire IT system lifecycle, including maintenance, incident management, and risk assessments.
Conducting system reviews to verify compliance and security controls is also essential.
The ideal candidate will have a Bachelor's degree in engineering, Computer Science, or a related field, with at least 5 years of experience in computerized system validation within pharmaceutical or life sciences projects.
Strong knowledge of GxP documentation and regulatory audits is necessary, along with the ability to independently create validation documentation. Familiarity with pharmaceutical manufacturing processes, especially Fill/Finish, is preferred.