Bachelor's degree in Engineering, Computer Science or related discipline.
3-5+ years of CSV experience in an FDA regulated industry.
Strong understanding of cGMP and FDA 21 CFR Part 11 and EU Annex 11 regulations.
Knowledge of data integrity requirements and assessment processes.
Experience qualifying both on-premises and cloud-based systems like SaaS, PaaS, IaaS.
Ability to influence at all organizational levels regarding compliance matters.
Proven experience in managing complex validation projects and meeting timelines.
Responsibilities
Provide compliance guidance using a risk-based approach focused on patient safety and data integrity.
Develop and implement CSV and CSA procedures aligned with system risk and intended use.
Generate and execute system life cycle deliverables per GAMP 5 guidelines and risk-based methodology.
Evaluate new computerized systems for GxP impact and define aligned validation strategies.
Review vendor documentation and perform independent verification for compliance.
Support change control and CAPA for computer systems.
Manage decommissioning processes for end-of-life systems.
Benefits
Opportunity to work in a GxP-compliant environment.
Exposure to a variety of computerized systems and applications.
Collaborative work with cross-functional project teams.
Continuous learning through evolving regulatory requirements and practices.
Full Job Description
About the job:
The Computer Systems Validation Engineer will be responsible for ensuring GxP computerized systems, including both on premises and Cloud/Server based applications, are validated and controlled in compliance with industry standards and regulations. The CSV Engineer will be primarily responsible for validating manufacturing, laboratory, and enterprise computerized systems. Other responsibilities include drafting system documentation, conducting risk assessment, and providing validation lifecycle management.
Roles And Responsibilities:
Provide CSV and CSA-based compliance guidance to the IT function, system owners, and business stakeholders, applying a risk-based approach focused on patient safety, product quality, and data integrity.
Lead the development, harmonization, implementation, and adherence to CSV and CSA procedures, ensuring validation effort is commensurate with system risk, intended use, and GxP impact.
Generate/Revise/Execute system life cycle deliverables using a risk-based CSA methodology and GAMP 5 guidelines (including URS, SRS, FRS, DDS, RTM, User Acceptance testing, FAT, SAT, Validation Planning, IQ, OQ, PQ, Risk Assessments and Final Validation Summary Report as applicable)
Evaluate proposed new computerized systems and software to determine GxP impact, system criticality, and intended use, and define a CSA aligned validation strategy that balances compliance, efficiency, and business needs.
Review and assess vendor supplied documentation and testing evidence, leveraging supplier activities where appropriate, and perform independent risk-based verification to ensure compliance with internal requirements and regulatory expectations.
Support change control activities, deviation resolution, CAPA, and effectiveness checks for computer systems.
Manage and execute decommissioning activities for retired or end of life systems.
Ensure that suppliers of IT services and solutions are properly assessed to determine their level of compliance and ensure that appropriate controls are in place based on risk.
Participate in project teams executing various validation projects and communicate project plans, status updates and progress against milestones to project team members.
Maintain up to date knowledge of evolving regulatory requirements regarding computer systems and act as an information resource for the team and business stakeholders.
Support internal and external audits and regulatory inspections.
Perform other validation engineering duties as assigned.
Qualification:
Bachelor's degree in Engineering, Computer Science or related discipline.
Must have 3-5+ years of CSV experience in an FDA regulated industry.
Strong knowledge and understanding of current Good Manufacturing Practices (cGMP) and FDA 21 CFR Part 11and EU Annex 11 regulations and standards.
Understanding of data integrity requirements and how to perform assessments.
Knowledge and experience with qualifying on premises and externally hosted (SaaS, PaaS, IaaS) software systems.
Ability to work with and influence people at all levels in matters related to CSV,CSA and GxP compliance.
Demonstrated experience in successfully managing complex validation projects and maintaining validation requirements and timelines.
Understanding of quality systems such as change control and discrepancy investigations.
Experience working with IT for qualification of network and infrastructure.
Demonstrated written and verbal communication skills.
Proficient with Microsoft Office, particularly Word and Excel.
High degree of initiative and self-motivation.
Experience creating technical, written content.
Ability to mentor team members and colleagues.
Preferred Qualifications:
Experience with systems like LabWare LIMS, MasterControl, SAP, Blue Mountain, Environmental Monitoring Systems (EMS), and IT infrastructure components.
