CSV Senior Compliance Advisor

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.

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.

Employee perks, benefits

• Bonus in compliance with internal principles
• Stable international work environment within a growing organization
• Home office possibilities
• Flexible working hours
• Development trainings
• Career opportunities for internal employees
• Employee referral program
• Global recognition program
• Employee contribution to meal allowance of 0.44 € per meal unit / day
• Employer contribution to supplementary pension savings
• Life insurance fully paid by the employer
• Social fund (various support and perks for employees)
• Free company transport for all employees
• Support for employee teambuilding activities
• Discounts with selected providers of goods and services