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
Contact the Recruiter
Lucia Velasco
Email: [email protected]
Phone: +32 493 89 16 33
关于高知特 (Cognizant)
高知特(Cognizant)（纳斯达克代码：CTSH）作为一家AI Builder和相关技术服务提供商，致力于通过打造全栈AI解决方案，帮助企业将人工智能投资转化为实际价值。公司凭借深厚的行业经验、流程优化和工程技术专长，将企业独特的业务场景融入科技系统，赋能组织释放人才潜能，推动切实成果，并帮助全球企业在瞬息万变的环境中保持领先。如需了解更多详情，敬请访问 cognizant.ai 或关注@cognizant。
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