Validation Engineer
il y a 3 jours
Process Validation EngineerAre you ready to support advanced cell therapy manufacturing in a highly regulated environment? As a Process Validation Engineer at MindCapture, you work on site in Ghent and play a key role in executing and documenting validation activities linked to aseptic operations. You work closely with Operations and QA, combining hands on execution with strong technical writing and cross functional collaboration.What is offeredReady to grow your career and make real impact? Join MindCapture.You will join MindCapture as a consultant supporting validation activities within a regulated cell therapy environment.We offer two collaboration options and you can choose what fits you best.As an employeeYou receive a competitive salary package with meal vouchers eco vouchers DKV health insurance group insurance net expense allowance and company car options. You benefit from personalised training coaching and a clear long term development path within large scale capital project delivery.As a freelancerYou work in a transparent collaboration model with competitive daily rates long term assignments professional support and continuity within complex pharmaceutical investment programs.In both cases, you work as a MindCapture consultant for an international market leader in the biotech industry.Job descriptionIn this role you strengthen the Manufacturing Excellence validation team and contribute to planning, executing and documenting process validation activities within aseptic operations.Plan plus execute media fill activities in close collaboration with operations. Coordinate runs, support preparation plus follow up, assess the impact of process changes plus ensure timely documentation.Define validation strategy plus coordinate activities such as sterilisation validation, hold time validation plus APQ.Write, review plus support approval of validation plans, protocols plus reports. Ensure content is clear, complete plus audit ready.Ensure revalidation of manufacturing processes plus sterilisation processes. Keep validation status current through periodic review plus updates.Participate in product transfer activities plus system introduction teams. Work closely with operations plus QA across different levels of the organisation.Contribute to system plus process improvement projects. Support optimisation initiatives based on deviations, trends plus lessons learned.Review technical reports plus supporting information. Confirm validations plus procedures align with current industry expectations, regulatory requirements plus available technology.Support smoke studies where required. Help set up CCIT activities plus support stability studies setup plus maintenance.RequirementsBachelor degree or higher in engineering biotech biomedical sciences or pharmacyExperience in pharma biotechnology cell therapy or a related regulated industryStrong working knowledge of current GMPHands on experience with validation documentation from protocol to reportExperience with product introduction to manufacturing sites and understanding of unit operationsAbility to interact effectively at different organisational levelsAbility to work under pressure manage priorities and make decisionsProject management mindset with structured and timely reportingFluent in English written and spokenAre you ready to make a real difference in healthcare?Join our dynamic team and help drive innovation in advanced therapies.Apply now and let’s make an impact together.Want to learn more? Discover all opportunities at www.mindcapture.com
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