Computer Systems Engineer
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We offer
competitive salaries, a full benefits package (meal vouchers, eco vouchers, DKV health insurance, group insurance, net expense allowance and a company car). You also get the opportunity to shape your future through personalised 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
- Develop, implement and execute validation studies for GMP critical computerised systems
- Prepare user requirements, system assessments, qualification protocols, review activities and traceability documentation
- Generate and maintain validation protocols, reports and supporting documentation throughout the system life cycle
- Ensure systems remain compliant with GMP, GLP and applicable procedures
- Monitor evolving regulatory requirements and provide technical input on validation practices
- Assess system changes and their impact on validated status
- Investigate validation related issues and support effective resolution
- Manage validation activities according to agreed scope, timelines and quality expectations
- Act as a subject matter expert during audits, change assessments and troubleshooting activities
Requirements:
- Bachelor’s or Master’s degree in science, engineering or a related technical field
- Minimum three years of experience within a GMP pharmaceutical environment
- Strong knowledge of computer systems validation and related methodologies
- Solid understanding of GMP, GLP, GAMP, FDA and EU requirements
- Experience validating software packages and computerised systems
- Strong troubleshooting and problem solving capabilities
- Clear communication skills with the ability to collaborate across teams and stakeholder groups
- Independent, structured and proactive working approach
- Fluency in Dutch and English Are you ready to make a real difference in healthcare? Join our dynamic team and help drive innovation in medical devices. Apply now and let’s make an impact together Want to learn more? Discover all opportunities at www.mindcapture.com. *If MindCapture sees a potential fit, we’ll get in touch as soon as possible.
* *If you don’t hear from us within two weeks, it simply means that this particular position wasn’t the right match. In that case, we’ll gladly keep
your profile
in mind for future roles that could suit you better.*
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