Deloitte GmbH Wirtschaftsprüfungsgesellschaft
Senior Consultant IT Quality & CSV / Life Sciences(m/w/x)
Full-timeWith HomeofficeSenior
Berlin, Düsseldorf, Frankfurt am Main, Köln, München
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MIMiltenyi Biotec
Computerized System Validation Manager(m/w/x)
Bergisch Gladbach
Full-timeWith Home OfficeExperienced
Nejo AI Summary
QA oversight for validation and qualification of computerized systems in cell and gene therapy development. Experience in GxP-regulated validation/qualification, with CSV and data integrity knowledge, required. Mobile working.
Requirements
- University degree or equivalent professional experience in a relevant field (ideally biosciences, pharmacy, or engineering)
- Experience in validation and qualification within GxP-regulated environment (preferably pharmaceutical or biotechnology industry)
- Solid understanding of CSV, GxP, and data integrity principles
- Familiarity with EU and FDA regulatory expectations
- Experience in reviewing technical documentation
- Ability to apply quality standards in a structured, detail-oriented manner
- Confidence working with digital tools and platforms (e.g., VEEVA)
- Experience with Ennov (a plus)
- Clear and fluent communication in English (C1)
- Effective cross-departmental collaboration skills
Tasks
- Provide QA oversight and support for validation and qualification activities.
- Execute validation and qualification activities, including CSV.
- Oversee validation and qualification activities, including CSV.
- Ensure compliance with GxP, data integrity, and QMS.
- Collaborate with cross-functional teams.
- Align validation efforts with the QMS.
- Contribute to continuous improvement of QA processes.
- Contribute to continuous improvement of QA documentation.
- Review validation documentation (plans, protocols, reports, risk assessments).
- Approve validation documentation (plans, protocols, reports, risk assessments).
- Ensure documentation accuracy and regulatory alignment.
- Develop and maintain QA documentation (SOPs, work instructions, templates, tools).
- Guide and train teams on QA expectations.
- Cover validation, qualification, and change management topics.
- Provide QA review and approval for changes.
- Ensure proper assessment and control of changes impacting validated systems.
- Ensure structured documentation.
- Ensure controlled access.
- Ensure reliable version management.
- Contribute to additional QA tasks as needed.
Work Experience
- approx. 1 - 4 years
Education
- Bachelor's degree
Languages
- English – Business Fluent
Tools & Technologies
- VEEVA
- Ennov
Benefits
Flexible Working
- Flexible time management
- Mobile working
Informal Culture
- Intercultural environment
- Flat hierarchies
Purpose-Driven Work
- Creative contribution
- Active role in shaping company
Learning & Development
- Individual further training
- Miltenyi University
More Vacation Days
- 30 days of vacation
Corporate Discounts
- Discounted ticket to Germany
Company Bike
- (e)-bike leasing
Additional Allowances
- Capital-forming benefits
Retirement Plans
- Company pension plan
Other Benefits
- Disability insurance
Free or Subsidized Food
- Canteen
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of Miltenyi Biotec 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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MIMiltenyi Biotec
Computerized System Validation Manager(m/w/x)
Bergisch Gladbach
Full-timeWith Home OfficeExperienced
Nejo AI Summary
QA oversight for validation and qualification of computerized systems in cell and gene therapy development. Experience in GxP-regulated validation/qualification, with CSV and data integrity knowledge, required. Mobile working.
Requirements
- University degree or equivalent professional experience in a relevant field (ideally biosciences, pharmacy, or engineering)
- Experience in validation and qualification within GxP-regulated environment (preferably pharmaceutical or biotechnology industry)
- Solid understanding of CSV, GxP, and data integrity principles
- Familiarity with EU and FDA regulatory expectations
- Experience in reviewing technical documentation
- Ability to apply quality standards in a structured, detail-oriented manner
- Confidence working with digital tools and platforms (e.g., VEEVA)
- Experience with Ennov (a plus)
- Clear and fluent communication in English (C1)
- Effective cross-departmental collaboration skills
Tasks
- Provide QA oversight and support for validation and qualification activities.
- Execute validation and qualification activities, including CSV.
- Oversee validation and qualification activities, including CSV.
- Ensure compliance with GxP, data integrity, and QMS.
- Collaborate with cross-functional teams.
- Align validation efforts with the QMS.
- Contribute to continuous improvement of QA processes.
- Contribute to continuous improvement of QA documentation.
- Review validation documentation (plans, protocols, reports, risk assessments).
- Approve validation documentation (plans, protocols, reports, risk assessments).
- Ensure documentation accuracy and regulatory alignment.
- Develop and maintain QA documentation (SOPs, work instructions, templates, tools).
- Guide and train teams on QA expectations.
- Cover validation, qualification, and change management topics.
- Provide QA review and approval for changes.
- Ensure proper assessment and control of changes impacting validated systems.
- Ensure structured documentation.
- Ensure controlled access.
- Ensure reliable version management.
- Contribute to additional QA tasks as needed.
Work Experience
- approx. 1 - 4 years
Education
- Bachelor's degree
Languages
- English – Business Fluent
Tools & Technologies
- VEEVA
- Ennov
Benefits
Flexible Working
- Flexible time management
- Mobile working
Informal Culture
- Intercultural environment
- Flat hierarchies
Purpose-Driven Work
- Creative contribution
- Active role in shaping company
Learning & Development
- Individual further training
- Miltenyi University
More Vacation Days
- 30 days of vacation
Corporate Discounts
- Discounted ticket to Germany
Company Bike
- (e)-bike leasing
Additional Allowances
- Capital-forming benefits
Retirement Plans
- Company pension plan
Other Benefits
- Disability insurance
Free or Subsidized Food
- Canteen
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of Miltenyi Biotec 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
Miltenyi Biotec
Industry
Pharmaceuticals
Description
Das Unternehmen entwickelt einzigartige Lösungen für die biomedizinische Spitzenforschung sowie neuartige Zell- und Gentherapien.
Not a perfect match?
- Deloitte GmbH Wirtschaftsprüfungsgesellschaft
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Full-timeWith HomeofficeExperiencedBerlin, Leverkusenfrom 129,700 - 163,800 / year - Madaus GmbH
Compliance Specialist & Qualified Person(m/w/x)
Full-timeWith HomeofficeExperiencedTroisdorf - CAPGEMINI SERVICE SAS
Junior IT Validation lead(m/w/x)
Full-time/Part-timeWith HomeofficeJuniorBerlin, Hamburg, München, Köln, Frankfurt am Main, Stuttgart, Dortmund, Hannover, Nürnberg, Karlsruhe - DEG FedEx Express Deutschland GmbH
Senior Healthcare Quality Engineer(m/w/x)
Full-timeWith HomeofficeSeniorKöln