CSV Senior Compliance Advisor Labs & Test Equipment

About the Role

The Computer Systems Validation (CSV) Senior Compliance Advisor will play a critical role in ensuring that laboratory systems and computercontrolled 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 sitebased QC R&D Engineering Validation and Quality teams.

Key Responsibilities:

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 computercontrolled 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 riskbased 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 CSVrelated 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 riskbased approaches.

• Maintain uptodate 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.

Skills & Experience:

• 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 computercontrolled 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…