CH12 Lonza AG
Senior Process Validation Expert(m/w/x)
Full-timeWith HomeofficeSenior
Visp
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You will ensure the highest quality standards by managing complex cleaning validation activities and technical assessments, serving as a key expert during critical inspections and audits.
Requirements
- Master’s or PhD degree in biotechnology, life sciences, or related disciplines
- Working experience in biopharma cleaning or cleaning validation
- Experience in cGMP-regulated biopharmaceutical environment
- Understanding of biologics manufacturing and cleaning regulatory requirements
- Proven experience in managing complex projects
- Ability to manage multiple tasks and meet deadlines
- Exposure to process development or manufacturing (advantageous)
- Experience engaging with regulatory agencies (advantageous)
- Excellent communication, technical writing, and stakeholder management skills
- Fluency in English; German is an advantage
- Ability to work on site in Visp 60% of the time
Tasks
- Develop and coordinate equipment cleaning activities
- Collaborate with operations, QA, and QC teams
- Implement validated cleaning methods in routine manufacturing
- Prepare and organize project-specific cleaning documentation
- Conduct technical assessments of carryover for cleaning
- Review and approve buffer cleaning validation reports
- Manage clean and dirty hold time documentation
- Perform annual cleaning reviews of the facility
- Coordinate troubleshooting and support deviation investigations
- Approve non-conformity records and change requests
- Serve as the primary counterpart for validation experts
- Represent the facility as a cleaning SME during audits
Work Experience
approx. 1 - 4 years
Education
Master's degree
Languages
English – Business FluentGerman – Basic
Tools & Technologies
cGMPmammalian manufacturing processbiologics manufacturing processMSATQualityprocess developmentupstream/downstream processesscale-upmammalian cell cultureSwissmedicFDA
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of Lonza and processed the information on Nejo with the help of AI for you. Despite careful analysis, some information may be incomplete or inaccurate. Please always verify all details in the original posting! Content and copyrights of the original posting belong to the advertising company.
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You will ensure the highest quality standards by managing complex cleaning validation activities and technical assessments, serving as a key expert during critical inspections and audits.
Requirements
- Master’s or PhD degree in biotechnology, life sciences, or related disciplines
- Working experience in biopharma cleaning or cleaning validation
- Experience in cGMP-regulated biopharmaceutical environment
- Understanding of biologics manufacturing and cleaning regulatory requirements
- Proven experience in managing complex projects
- Ability to manage multiple tasks and meet deadlines
- Exposure to process development or manufacturing (advantageous)
- Experience engaging with regulatory agencies (advantageous)
- Excellent communication, technical writing, and stakeholder management skills
- Fluency in English; German is an advantage
- Ability to work on site in Visp 60% of the time
Tasks
- Develop and coordinate equipment cleaning activities
- Collaborate with operations, QA, and QC teams
- Implement validated cleaning methods in routine manufacturing
- Prepare and organize project-specific cleaning documentation
- Conduct technical assessments of carryover for cleaning
- Review and approve buffer cleaning validation reports
- Manage clean and dirty hold time documentation
- Perform annual cleaning reviews of the facility
- Coordinate troubleshooting and support deviation investigations
- Approve non-conformity records and change requests
- Serve as the primary counterpart for validation experts
- Represent the facility as a cleaning SME during audits
Work Experience
approx. 1 - 4 years
Education
Master's degree
Languages
English – Business FluentGerman – Basic
Tools & Technologies
cGMPmammalian manufacturing processbiologics manufacturing processMSATQualityprocess developmentupstream/downstream processesscale-upmammalian cell cultureSwissmedicFDA
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of Lonza and processed the information on Nejo with the help of AI for you. Despite careful analysis, some information may be incomplete or inaccurate. Please always verify all details in the original posting! Content and copyrights of the original posting belong to the advertising company.
About the Company
Lonza
Industry
Pharmaceuticals
Description
Lonza is a global leader in life sciences, committed to improving lives through innovative solutions and ethical practices.
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