CSV Senior Compliance Advisor

Náplň práce, právomoci a zodpovednosti:

We are building a new R&D team as part of the Convatec Technology Development Center in Slovakia. With new offices, laboratories, and prototyping facilities, we are looking for motivated professionals seeking a meaningful job in a medical company known for its stability and resilience - a company that has continued to grow without experiencing any crises and with a wide global product portfolio for people all over the world. If you enjoy taking up challenges, learning new things, having the space to bring your ideas to life, and wish to join a high-performing team, do not hesitate to contact us. We are looking forward to hearing from you. 
Since 2012, we have been building our R&D dream and investing significant capital into our capability and now we want to invest in you.

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:

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.

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.

Zamestnanecké výhody, benefity:

• 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 – Convatec Champions

• 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 within Michalovce for all employees

• Support for employee teambuilding activities

• Discounts with selected providers of goods and services

Požiadavky na zamestnanca: