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CSV Validation Engineer, QA

Are you looking for a career that matters?We believe every person deserves a chance for a healthy life, free from illness and full of possibility. We see a world full of healing, with viable care options available to those with limited choices today. We envision new ways of providing physicians, pharmacists and nurses with technologies that not only treat chronic diseases, but also work to prevent them. We’re looking for team members who are motivated to learn, grow and innovate, while making a meaningful difference for millions of people around the world.Learn more about how Baxter is At the Intersection of Saving and Sustaining Lives.SummaryBased in Lessines, we are looking for an experienced Validation Engineer who will have the main following activities:Coordinate and assist in qualification activities for processes validation, equipment qualification for the Sterile Drugs department and computerized systems in SD and Plastics departments in accordance with internal and legal requirements.Ensure compliance of validation processes used in the Sterile Drugs and Plastic departments through the establishment GMP compliant validation.Essential Duties and ResponsibilitiesAct as a validation representative for projects and periodic evaluation that include computerized system validation and qualification activities :Define the validation methodology and approach for the project.Provide validation expertise and quality assurance guidance for the development of the project: direct involvement in the definition of the process/system specifications.Participate in the risk assessment related to the project.Review URS, FS and DS for validation requirements and all applicable QA requirements. Participate in the determination of process or system controls.Participate as part of the project team in the definition of the user requirements and functional specifications of automated processesPrepare validation documentation in compliance with Baxter and cGMP requirements and assure application of these requirementsPrepare and implement FAT, IQ, OQ & PQ Protocols.Assure traceability throughout the whole project validation file (from URS to PQ).Organize and coordinate FAT, IQ, OQ, PQ activities with the different involved departments and in such a way that all of them concur to the timeframes committed with the project leader.Analyze, interpret, document and report the testing results.Collect and approve results of validation activities, assure issuance of reports and allow release of impacted product in accordance to internal proceduresParticipate in the writing of specifications and SOP’s related to automated manufacturing processesMaintain the validated state through the change control process: analysis of changes, definition of tests to be performed and approval of resultsEnsure the follow-up and tracking of the validation’s activities. Update the validation documentation system.Maintain the validated state through the periodic evaluation processDevelop procedures in compliance with Corporate and Industry requirementsDevelop and deliver training to employeesOptimize the compliance program by showing expertise and leveraging resources with IS manufacturing, and other shared servicesBenchmark of compliance program, inside and outside the companyDevelop and manage (re)validation program regarding the computerized systemsParticipate in the communication of the good validation practicesQualificationsMaster in Engineering or Science or equivalent through experienceNumber of years of experience: minimum 5 years in pharmaceutical industriesKnowledge of Validation activities with knowledge in computerized systemGood knowledge of English and French languagesGood knowledge of GMPTeamwork orientatedGood communication skillsGood problem solving and critical thinking skillsKnowledge of Pharmaceutical Industry requirementsGood understanding of industrial processes and industrial control systemsGood knowledge of current European and FDA regulationsKnowledge of Information and Automated systemsReasonable AccommodationsBaxter is committed to working with and providing reasonable accommodations to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please send an e-mail to Americas_TTA@baxter.com and let us know the nature of your request along with your contact information.Full time

CSV Validation Engineer, QA

Baxter International, Lessines
Categories: 
Engineering
Degree Level: 
Master
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