CSV Validation Engineer, QAReq # JR - 026951 Location Lessines, Wallonia, Belgium Job Category Quality Control Date posted 09/04/2020
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Based 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 Responsibilities
- Act 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 processes
- Prepare validation documentation in compliance with Baxter and cGMP requirements and assure application of these requirements
- Prepare 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 procedures
- Participate in the writing of specifications and SOP’s related to automated manufacturing processes
- Maintain the validated state through the change control process: analysis of changes, definition of tests to be performed and approval of results
- Ensure the follow-up and tracking of the validation’s activities. Update the validation documentation system.
- Maintain the validated state through the periodic evaluation process
- Develop procedures in compliance with Corporate and Industry requirements
- Develop and deliver training to employees
- Optimize the compliance program by showing expertise and leveraging resources with IS manufacturing, and other shared services
- Benchmark of compliance program, inside and outside the company
- Develop and manage (re)validation program regarding the computerized systems
- Participate in the communication of the good validation practices
- Master in Engineering or Science or equivalent through experience
- Number of years of experience: minimum 5 years in pharmaceutical industries
- Knowledge of Validation activities with knowledge in computerized system
- Good knowledge of English and French languages
- Good knowledge of GMP
- Teamwork orientated
- Good communication skills
- Good problem solving and critical thinking skills
- Knowledge of Pharmaceutical Industry requirements
- Good understanding of industrial processes and industrial control systems
- Good knowledge of current European and FDA regulations
- Knowledge of Information and Automated systems
Baxter 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.