CSV engineer

Il y a 1 jour

Flemish Brabant, Belgique MindCapture Temps plein

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MindCapture is looking for a Validation Engineer to take GMP critical systems to the next level. What’s in it for you: challenging projects at an international healthcare leader, a competitive salary package with full benefits, and plenty of room to grow your career. Are you skilled in CSV, GMP and troubleshooting? This is your chance to truly make a difference. What is offered Ready to grow your career and make real impact? Join MindCapture

We offer
competitive salaries, a full benefits package (meal vouchers, eco vouchers, DKV health insurance, group insurance, net expense allowance, and a company car) — plus the opportunity to shape your future through personalized training and development. At MindCapture, you choose what you love, build on your strengths, and make a difference where it matters most. You will work as a MindCapture consultant for an international market leader in the healthcare industry.

Job Description
As CSV Validation Engineer you will ensure that GMP critical computerised systems are validated, compliant and fit for purpose. You will manage validation activities from documentation to execution and act as subject matter expert in audits, change assessments and troubleshooting.
• Validation execution: Develop, implement and execute validation studies for GMP critical computerised systems including URS, SIA, DQ, IQ, OQ, PQ, RV and TM activities
• Documentation: Generate and maintain validation protocols, reports and supporting documentation, ensuring traceability and approval across the lifecycle
• Regulatory compliance: Validate systems in line with GMP, GLP and company procedures, keeping validated status current at all times
• Industry expertise: Stay up to date with evolving FDA and EU requirements, providing technical input on validation testing practices
• Change assessment: Review system changes and assess impact on validated status, ensuring documentation and compliance updates are completed
• Troubleshooting: Investigate and resolve validation related issues, supporting projects and operations to maintain compliance
• Project alignment: Ensure validation activities are managed in line with company and regulatory standards, meeting scope, timing and quality requirements

Requirements:
• Bachelor or Master degree in Sciences, Engineering or a related technical field
• Minimum of 3 years of experience in a GMP pharmaceutical environment
• Strong knowledge of Computer Systems Validation and related methodologies
• Solid understanding of quality and compliance regulations such as GAMP, FDA and EU guidelines
• Experience with validation of software packages and computerised systems
• Ability to troubleshoot validation issues effectively
• Strong communication skills, able to collaborate across teams and stakeholders
• Capable of working independently with a structured and proactive approach
• Fluent in Dutch and English Are you ready to make a real difference in pharma? Join our dynamic team and help drive innovation in healthcare. Apply now and let’s make an impact together Want to learn more? Discover all opportunities at www.mindcapture.com.

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Asie / Océanie

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CSV engineer

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