Description - External
Job Title: Instrument Validation Specialist
Location: Brussels, Belgium (ITBEL Brussels BC - Tour & Taxi - COG)
Work Model: Hybrid
Shift: Day Shift
Travel Required: No
Experience Level: Mid to Senior Level (6–10+ years) About the Role
We are looking for an experienced Instrument Validation Specialist to join our team in Brussels. In this role, you will be responsible for ensuring compliance and validation of laboratory instrument software within a regulated GxP environment. You will play a critical role in aligning software validation processes with EMA standards and internal IT SOPs while collaborating closely with cross-functional teams. Key Responsibilities
Document and validate software installed on lab instruments in accordance with EMA regulatory standards
Migrate instrument software management processes to align with PPD IT SOPs
Capture, analyze, and document software requirements and configurations
Develop validation test cases, protocols, and supporting documentation for instrument and medical device validation
Create infrastructure diagrams and data flow mappings
Conduct comprehensive risk assessments to ensure compliance and system integrity
Collaborate with IT, QA, and laboratory operations teams to ensure successful validation lifecycle execution Required Skills & Qualifications
Proven experience in instrument or medical device validation within a regulated GxP environment
Strong technical writing skills with experience in validation documentation and test case development
Excellent communication and stakeholder management skills
High attention to detail with a strong focus on compliance and accuracy
Solid understanding of EMA guidelines and IT SOPs within pharmaceutical or medical device environments
Experience with risk assessment methodologies and validation lifecycle documentation Preferred Experience
6–10+ years of relevant experience in validation roles
Prior experience with laboratory instrumentation software validation is highly desirable What We Offer
Health insurance
Life cover
Company car or mobility budget
Work-from-home allowance
32 vacation days
Pension plan
Luncheon vouchers
Travel insurance
EcoCheques
Travel & entertainment cost reimbursement
Laptop
Mobile phone with subscription
