CSV Senior Compliance Advisor - Labs & Test Equipment

The Computer Systems Validation (CSV) Senior Compliance Advisor will play a critical role in ensuring that laboratory systems and computer-controlled test equipment supporting GxP activities are validated and maintained in a compliant state in accordance with regulatory requirements and corporate quality standards. This role is heavily focused on laboratory and test environments within a medical device manufacturing organization, including systems and equipment used for product testing, verification, and quality assurance. The role requires close collaboration with site-based QC, R&D, Engineering, Validation and Quality teams., The CSV Senior Compliance Advisor will support and oversee CSV activities for laboratory systems and test equipment, ensuring systems are inspection-ready, data integrity principles are applied, and validated systems remain fit for intended use throughout their lifecycle. Laboratory & Test Equipment CSV

• Lead CSV activities for laboratory systems and computer-controlled test equipment used in medical device development, testing, and manufacturing support.
• Support validation and qualification of test equipment and automated test systems, including software used to control, acquire, process and store GxP data.
• Ensure appropriate alignment between equipment qualification (IQ/OQ/PQ) and computerized system validation.
• Assess GxP impact of laboratory instruments, test equipment, software applications and interfaces, including data acquisition, processing and reporting workflows.
• Ensure data integrity (ALCOA+) principles are embedded within laboratory and test systems and associated documentation.
• Partner closely with QC, laboratory, engineering and validation teams to understand workflows and translate them into compliant CSV strategies.
Implementation Projects
• Evaluate proposed new or modified laboratory systems and test equipment to define appropriate risk-based validation approaches.
• Work closely with project managers and site stakeholders to ensure CSV milestones are met throughout the project lifecycle.
• Oversee and/or develop validation deliverables, including:
• Validation Plans
• User Requirements Specifications (URS)
• Risk Assessments
• Traceability Matrices
• Test Scripts and Protocols
• Validation Reports
• Support validation of interfaces between test equipment, laboratory systems and downstream data repositories.
• Review and approve validation documentation to ensure compliance with regulatory requirements and company quality standards.
• Coach project and laboratory teams in the correct execution of CSV documentation and testing activities.
System Lifecycle & Ongoing Compliance
• Review proposed changes to validated laboratory systems and test equipment and define required change control and revalidation activities.
• Ensure changes are implemented and documented in a compliant manner.
• Perform periodic reviews to confirm systems and equipment remain in a validated state.
• Support investigations into CSV-related deviations, discrepancies and data integrity issues, ensuring timely resolution and documentation.
Quality & Regulatory Oversight
• Conduct quality reviews of CSV deliverables to identify risks, gaps and opportunities for improvement.
• Support and perform supplier assessments for laboratory software, test equipment and service providers, applying risk-based approaches.
• Maintain up-to-date knowledge of regulatory expectations and inspection trends related to CSV and test systems in medical device environments.
• Act as a CSV subject matter expert supporting QA, validation and laboratory stakeholders.
  
  Strong understanding of GxP and medical device regulations, including:
• 21 CFR Part 820 (QSR)
• 21 CFR Part 11
• EU Annex 11
• GAMP 5
• Demonstrated experience validating laboratory systems and computer-controlled test equipment.
• Experience with laboratory and test systems such as LIMS, CDS, ELN and software controlling or supporting device testing and verification activities.
• Strong understanding of data integrity expectations in laboratory and test environments.
• Experience supporting CSV in medical device manufacturing or development environments.
• Ability to communicate effectively with laboratory scientists, engineers, validation specialists and quality professionals.
• Strong organizational skills with the ability to manage multiple priorities in a regulated environment., Bachelor's degree in Life Sciences, Engineering, Computer Science or related field.
• 5+ years' experience in CSV, with a strong focus on laboratory systems and/or test equipment.
• Experience in CSV, QA, validation or compliance roles within the medical device industry.
• Excellent documentation, presentation and written communication skills.