CSV Execution Engineer
Jobdescription
Role Overview :
Lonza isseeking a skilled CSV Execution Engineer to join our team at theVisp site. In this role, you will be responsible for supportingassigned projects through the accurate execution of validationprotocols.
You will collaborate closely with various teams,including Process Engineers, Automation Team, Project Managers, andQuality Assurance, to ensure that timelines are met and thatcompliance with Lonza's CQV / CSV processes is maintained throughoutthe project lifecycle.
KeyResponsibilities :
- Participate insystem classification assessments and collaborate with CSV subjectmatter experts (SMEs).
- Create and execute CSVdocuments following Lonza’s standard operating procedures andguidelines, ensuring compliance with good documentation practices(GDocP).
- Engage in FAT and SAT testing andcreate detailed validation protocols andreports.
- Work closely with CSV Regional Leadsor CQV Leads to support operational teams on technical changes andlife cycle activities.
- Ensure that all GlobalEngineering projects comply with Lonza's CQV / CSV guidelines, localprocedures, and continuously work to detect and resolve any gaps incompliance.
RequiredQualifications :
- Technical degree(Bachelor’s level) in engineering or applied sciences, orequivalent experience.
- Experience in regulatedindustries or engineering environments, particularly in hands-onroles.
- Basic knowledge of ISPE GAMP5, ASTMguidelines, and regulatory requirements forGxP.
- Familiarity with biologics (mammalian,CGT) or chemical manufacturing technologies is highlydesirable.
- Understanding of automation and dataflow processes, as well as data integrity principles(ALCOA+).
Skills andCompetencies :
- Strong analytical skillsand experience working with complex data sets to supportdecision-making.
- Excellent collaborationskills, with the ability to work in a matrixenvironment.
- Proficiency in English, with astrong command of German (reading andwriting).
- Ability to prioritize taskseffectively and work both independently and within ateam.
At Lonza, we arecommitted to building a healthy, sustainable future. If you aremotivated, adaptable, and ready to contribute to a dynamicenvironment, we would love to hear fromyou!
CSV Execution Engineer
Lonza isseeking a skilled CSV Execution Engineer to join our team at theVisp site. You will collaborate closely with various teams,including Process Engineers, Automation Team, Project Managers, andQuality Assurance, to ensure that timelines are met and thatcompliance with Lonza's CQV/CSV processes ...
CSV Execution Engineer
Lonza is seeking a skilled CSV Execution Engineer to join our team at the Visp site. You will collaborate closely with various teams, including Process Engineers, Automation Team, Project Managers, and Quality Assurance, to ensure that timelines are met and that compliance with Lonza's CQV/CSV proce...
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