Computer Systems Validation (CSV) Senior Compliance Advisor

About [Employer hidden — view at passion-project.co.uk]

[Employer hidden] is a global medical products and technologies company, focused on solutions for the management of chronic conditions, with leading positions in Advanced Wound Care, Ostomy Care, Continence Care, and Infusion Care. With more than 10,000 colleagues, we provide our products and services in around 90 countries, united by a promise to be forever caring. Our solutions provide a range of benefits, from infection prevention and protection of at-risk skin, to improved patient outcomes and reduced care costs. [Employer hidden]’s revenues in 2024 were over $2 billion. The company is a constituent of the FTSE 100 Index (LSE:CTEC). To learn more please visit http://www.convatecgroup.com

About the Role

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 equipment in manufacturing 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, Quality and Manufacturing 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.

Your Contributions (include, but are not limited to):

Laboratory & Test Equipment CSV

• Lead CSV activities for laboratory systems and software/firmware-controlled test equipment used in medical device development, testing, and manufacturing support.
• Support validation of test equipment or laboratory system with firmware/software used to control, acquire, process and store GxP data.
• Ensure appropriate alignment between equipment qualification (IQ/OQ/PQ) and computerized system validation.
• Conduct CSV GxP risk assessment for all systems including simple and complex instruments. .
• Ensure site specific inventories are up to date.
• Ensure prompt storage of approved documents in validated storage location and applicable repositories as per the process.
• Ensure data integrity (ALCOA+) principles are embedded within laboratory and test systems and associated documentation.
• Cross functional collaboration 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 but are not limited to:

• 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.
• Initiate deviations as required, assess their impact, document corrective actions, and ensure timely closure.
• Coach project and laboratory teams in the correct execution of CSV documentation, testing activities and Good Documentation Practices

• Work with team members to drive the site forward for continuous improvement regarding validation processes
• Accountable for the accurate reporting and record maintenance of all CSV documentation packs.
• Act as a navigator to projects, providing clear direction and oversight by guiding teams through planning, execution, and delivery, while ensuring alignment with objectives, timelines, and regulatory or quality requirements.
• Identify and address non-conformances in relations to computer systems validation procedures and processes; ensure prompt resolution of identified problems via consultation with area Lead/manager and provide appropriate recommendations for remedial/corrective actions.

• To act as a technical expert on behalf of the organisation by providing advice, guidance and expertise on Computer system validation issues.

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.
• Ensure suitable technical responses to audits; support CAPA systems where appropriate by addressing any follow-up actions within the agreed timeframe.

Quality & Regulatory Oversight

• Conduct quality reviews of CSV deliverables to identify risks, gaps and opportunities for improvement.
• 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.

Skills & Experience:

• Strong understanding of GxP and medical device regulations, including:

• 21 CFR Part 11
• EU Annex 11
• GAMP 5
• Quality Management System Regulation (QMSR)

• Demonstrated experience validating laboratory systems and software/firmware-controlled test equipment.
• Hands on experience with laboratory and test systems such as GCMS, OpenLab CDS, ICPMS MassHunter, Burst Tester Lippke 4500/5000, Zwick, FTIR Omnic/MicroLab.
• Hands on experience with validation of client server/enterprise, web-based applications such as Waters Empower 3 FR4/3.8 CDMS, Vaisala View Linc Temperature and Humidity monitoring and alarming system.
• Experience in laboratory workflows.
• Experience in Saas based applications such as Laboratory Information Management Systems (LIMS) is a plus
• Experience validating enterprise IT applications such as MES, EDMS, TrackWise, ERP SAP is a plus
• Experience in migration of data from legacy systems to new systems, using both manual methods and automated tools.
• Strong understanding of data integrity expectations in laboratory and manufacturing environments.
• Experience supporting CSV in med tech/ pharma companies.
• Proven record of cross functional collaboration with laboratory scientists, engineers, validation specialists, quality professionals, manufacturing floor engineers, shift leads
• Strong organizational skills with the ability to manage multiple priorities in a regulated environment.

Qualifications / Education:

• Min. 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 required.
• Experience in CSV, QA, validation or compliance roles within the medical device industry.
• Excellent documentation, presentation and written communication skills.

Working Model / Location:

This role operates on a flexible hybrid working model, with on‑site presence required at our Deeside, Wales location on an as needed basis.

Travel Requirements:

Up to 10% travel, which may include overnight stays.