CSV Quality Engineer

Job Title

Support software lifecycle processes for non-product software in accordance with internal procedures and regulatory requirements. Ensure computerized systems and software used in support of manufacturing, quality management, and other GxP activities are developed, validated and maintained in compliance with applicable FDA, EU and other international regulations and ISO standards. Support quality risk assessment activities (e.g., system level risk assessment, functional risk assessment, change risk assessment) throughout the life cycle of computerized systems. Execute validation strategies and planning of validation activities; Oversee execution of validation activities for non-product computerized systems. Review and approve validation documentation including, but not limited to, risk assessments, validation plans, protocols (IQ/OQ/PQ), traceability matrices, and validation reports. Collaborate with IT, vendors, and functional departments to ensure systems are validated and maintained in their validated state. Maintain computer system inventory. Ensure validation documentation are retained per the company's retention policy and retrievable. Participate in change control processes to assess impact upgrades and changes on validated systems; Oversee execution of change actions. Coordinate and execute periodic reviews of validated systems per defined schedule; support development of remediation plan, if needed. Support audits and inspections by providing validation documentation and subject matter expertise. Provide guidance on software assurance and CSV principles and procedures to cross-functional teams. Support data integrity initiatives and ensure Part 11/Annex 11 compliance of electronic records and electronic signatures. Additional responsibilities may be assigned as necessary to support the business.