Validation Expert

As an IT team member part of the ITRMC (IT Risk Management & Compliance), you will play a crucial role in interfacing between the quality business unit, IT, business customers, and vendors on various computer system validation projects and compliance initiatives. Your primary responsibilities will include: - Providing technical and compliance expertise for the strategy and execution of computer systems validation, ensuring adherence to regulatory standards such as 21 CFR Part 11, 211, 820, GAMP, and CSA. - Performing IT change control impact assessments and collaborating with IT and business subject matter experts. - Developing computer system validation project documentation and artifacts, taking project lead or business analyst roles for assigned projects. - Running computer system validation efforts of varying complexity and sizes. - Offering coaching and guidance to stakeholders on validation best practices, risk management, and industry guidance. - Advising on IT project execution and infrastructure operations from a risk and compliance perspective. - Providing IT audit support for internal and external audit entities regarding health regulations and standards. - Staying updated on computer systems validation approaches, industry trends, and health agency guidance. - Supporting software supplier assessments to evaluate suppliers for engagement related to IT systems and processes. - Overseeing junior roles, staff augmentation, or vendor services for larger validation projects. - Taking ownership of IT life cycle compliance operations to ensure timely completion of activities and system compliance. Your qualifications should include: - Bachelor's degree in Computer Science, IT, or a science-related discipline. - Proficiency in English. - Being a U.S. or UK citizen. - 8+ years of experience in IT support functions within pharma regulated industries, specifically in the validation of laboratory, quality, or manufacturing-related IT systems. - Deep knowledge of lab systems, plant manufacturing systems, quality systems, Document Management Systems, CAPA processes, risk management, and audits typical for pharmaceutical manufacturing. - Clear experience with SDLC/GAMP and IT project management methodologies; Agile cGMP development knowledge is a plus. - Training and knowledge of FDA CSA. - Lean Six Sigma and/or ASQ certification are advantageous. You should have experience operating as the computer systems validation strategy lead, delivering validation packages, designing IT-regulatory compliance processes, performing risk management and gap-remediation, executing data integrity business programs, working within an SDLC framework, and providing coaching on validation and compliance operations.,