Lead - Computer System Validation (CSV)

Job Description

We are seeking an experienced Lead - Computer System Validation (CSV) professional to oversee and execute validation protocols for computer systems in a regulated life sciences environment. The ideal candidate will ensure that systems meet regulatory compliance standards and industry best practices. The role requires leadership in developing validation documentation, managing testing activities, and providing guidance to cross-functional teams. If you have a strong background in CSV and a proven ability to manage complex validation processes, we want to hear from you.

Responsibilities

• Develop and execute validation protocols for computer systems, ensuring they comply with relevant regulatory and industry standards.
• Create and maintain detailed validation documentation, including validation plans, reports, scripts, and other supporting materials.
• Conduct risk assessments and impact analysis related to computer systems to ensure potential risks are identified and mitigated.
• Coordinate and supervise testing activities related to system validation, ensuring that tests are executed effectively and according to the established protocols.
• Collaborate closely with cross-functional teams (e.g., IT, QA, Regulatory Affairs) to maintain and continuously improve system validation processes and practices.
• Monitor and report on validation project progress, including tracking timelines, milestones, and deliverables.
• Provide training and support to staff regarding system validation processes, industry requirements, and best practices.
• Ensure that validation practices are aligned with regulatory requirements, including FDA, EMA, GxP, and other applicable guidelines.
• Life Sciences : Expertise in Computer System Validation (CSV), particularly in regulated environments.
• Strong knowledge of regulatory requirements such as FDA, EMA, GxP, and industry standards related to system validation.
• Risk Management: Ability to assess and mitigate risks associated with computer systems and ensure compliance with industry best practices.
• Strong communication and collaborative skills to work across teams, influencing and guiding teams toward successful project outcomes.
  
  

Requirements:

• Bachelor's degree in Life Sciences, Computer Science, Engineering, or a related field.
• Advanced degree (e.g., Master's, PhD) is a plus but not required.
• 8-10 years of experience in Computer System Validation (CSV) within a regulated life sciences or pharmaceutical environment.
• Proven experience in developing and executing validation protocols for computer systems.
• In-depth knowledge of regulatory compliance (e.g., FDA, EMA, GxP).
• Strong understanding of risk assessments, impact analyses, and testing protocols.
• Ability to coordinate and supervise validation testing activities effectively.
• Demonstrated ability to work with cross-functional teams and influence the improvement of validation processes.
• Strong organizational skills with experience in monitoring and reporting validation project progress.
• Experience in providing training and support on validation processes to internal teams.
• Experience with computer system validation in specific areas such as ERP systems, LIMS, SCADA, and other regulated life sciences platforms.
• Previous experience in leading teams or acting as a project lead in validation projects.
• Professional certifications in validation or related fields (e.g., Certified Quality Engineer (CQE), Certified Software Validation Specialist (CSVS)).