Instrument/Medical Device Validation Specialist Location: Belgium About the role As an Instrument/Medical Device Validation Specialist, you will make an impact by ensuring compliance and validation of software installed on laboratory instruments in accordance with EMA guidelines. You will be a valued member of the project team and collaborate closely with IT, QA, and lab operations to support a critical initiative for software validation and migration. In this role, you will: Document and validate software installed on lab instruments per EMA regulatory standards. Migrate instrument software management to align with PPD IT SOPs. Capture and document software requirements and configurations. Develop validation test cases and protocols related to instruments/medical devices. Create infrastructure and data flow diagrams. Conduct comprehensive risk assessments. Collaborate with cross-functional teams including IT, QA, and lab operations. Work model We strive to provide flexibility wherever possible. Based on this role's business requirements, this is an onsite position in Belgium. Regardless of your working arrangement, we support a healthy work-life balance through various wellbeing programs. What you need to have to be considered Proven experience in instrument/medical device validation within a regulated (GxP) environment. Strong technical writing skills for documentation and test case development. Excellent communication skills to interact with cross-functional teams. Highly detail-oriented with a focus on compliance and accuracy. Familiarity with EMA guidelines and IT SOPs in pharmaceutical or medical device settings. Experience with risk assessment methodologies and validation lifecycle documentation. These will help you stand out Mid to senior-level experience (6-10 years) in relevant roles. Prior experience in lab instrumentation software validation. What we offer (Belgium) Health insurance and life cover Car or mobility budget Work-from-home allowance 32 vacation days Pension plan Luncheon vouchers Travel insurance EcoCheques Travel & entertainment cost coverage Laptop and mobile phone with subscription Contact the Recruiter Lucia Velasco Lucia.Velasco@cognizant.com 32 493 89 16 33 Cognizant is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by law.