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Engineering Validation
2 weeks ago
About the job
- Serve as a site Subject Matter Expert for at least 1 specialized validation area
- Planning, performance, support and coordination of Computer System Validation, Equipment validation, Sterilization In Place, cleanroom validation, Clean Utilities Validation (IQ/OQ/PQ/CPV)
- Maintain validation status of Computer System Validation
- Independently scheduling, organization and coordination of detailed site level validation activities with cross functional groups.
- Support data evaluation if necessary
- Ongoing feedback of validation status to responsible user
- Creation of SOPs or documentation related to the validation activities or maintenance
- Review and check documentation for GMP compliance
- Project support for system/equipment where validation is impacted
- Definition of relevant equipment investment projects and in creation of User Requirement specifications if required.
- Participate in audits
- Presentation of explanation of validation approach, projects and results
About you
- Bachelor's Degree or higher in biological/pharmaceutical sciences or engineering sciences. Equivalent degree or experience possible
- At least 4 years of working experience in Pharmaceutical/ GMP
- Specialized knowledge of relevant GMP guidelines
- Time management and organizational skills for specific projects
- Able to execute activities in cGMP environment, including cleanrooms or technical areas
- Enthusiastic and selfdriven
- Team player but able to work on own initiative
- Good communicator who enjoys working in a dynamic and multicultural environment
Equal opportunity
Job Types:
Full-time, Permanent
Schedule:
- Monday to Friday
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