Convatec
CSV Senior Compliance Advisor - Labs & Test Equipment
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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 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.
Key Responsibilities:
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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.
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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.
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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.
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- 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.
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 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.
Qualifications / Education:
- 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.
Working Model / Location:
This role operates on a hybrid working model, with on-site presence required.
Travel Requirements:
Up to 10% travel, which may include overnight stays.
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A formal recruitment process is required for all our opportunities prior to any offer of employment. This will include an interview confirmed by an official Convatec email address.
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Equal opportunities
Convatec provides equal employment opportunities for all current employees and applicants for employment. This policy means that no one will be discriminated against because of race, religion, creed, color, national origin, nationality, citizenship, ancestry, sex, age, marital status, physical or mental disability, affectional or sexual orientation, gender identity, military or veteran status, genetic predisposing characteristics, or any other basis prohibited by law.
Notice to Agency and Search Firm Representatives
Convatec is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Convatec employee by a third party agency and/or search firm without a valid written and signed search agreement, will become the sole property of Convatec. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you.
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About Convatec
Pioneering trusted medical solutions to improve the lives we touch:
Convatec 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 over 10,000 colleagues, we provide 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, treatment for hard to heal wounds, at-risk skin, and ulcerated tissue to supporting debilitating conditions, improved patient outcomes, and reduced care costs. Convatec's revenues in 2025 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
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