CSV

Develop and maintain computer system validation (CSV) policies, procedures, and documentation in alignment with regulatory requirements (e.g., FDA, EMA, GxP), industry standards (e.g., GAMP), and company quality management systems.

Lead and manage the execution of CSV projects, including risk assessments, validation planning, requirements gathering, testing, documentation, and validation reporting for computerized systems and software applications.

Collaborate with cross-functional teams, including IT, quality assurance, regulatory affairs, and business stakeholders, to ensure that computer systems and software applications meet user requirements, functional specifications, and compliance standards.

Conduct validation assessments and gap analyses for new or existing computer systems to identify validation gaps, risks, and opportunities for improvement, and develop remediation plans as needed.

Review and approve validation documentation, including validation plans, protocols, test scripts, traceability matrices, and validation reports, to ensure completeness, accuracy, and compliance with regulatory expectations.

Provide CSV guidance, training, and support to project teams, system owners, and validation professionals on validation principles, best practices, and regulatory expectations.

Stay informed about emerging trends, regulatory changes, and industry developments related to CSV, computerized systems, data integrity, and electronic records management, and recommend proactive measures to address evolving requirements.

Participate in regulatory inspections, audits, and assessments related to computer system validation, providing documentation, evidence, and support as needed to demonstrate compliance with regulatory requirements.

Diverse Lynx LLC is an Equal Employment Opportunity employer. All qualified applicants will receive due consideration for employment without any discrimination. All applicants will be evaluated solely on the basis of their ability, competence and their proven capability to perform the functions outlined in the corresponding role. We promote and support a diverse workforce across all levels in the company.