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Senior Qualification Engineer(m/w/x)
Description
In this role, you will take charge of the CQV strategy for a cutting-edge manufacturing site, managing qualification projects and ensuring compliance with the highest quality standards. Your expertise will shape the facility's operations while maintaining equipment qualifications and representing the department during audits.
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Upload your CV and Nejo AI will find matching job offers for you.
Requirements
- •Master's/Bachelor's degree in mechanical engineering, pharmaceutical technology, medical technology, chemistry, process engineering, or similar
- •Sound knowledge and several years of experience in plant qualification in a GMP surrounding
- •Good understanding of GMP, technical and bioprocess understanding, quality and safety awareness
- •Proactive collaboration with Customer Delivery, QA, and IT Circles
Education
Work Experience
2 - 5 years
Tasks
- •Lead the CQV strategy for the new manufacturing site
- •Independently plan and manage qualification projects
- •Engage specialized external companies for qualifications
- •Supervise and check assignments from external companies
- •Conduct qualifications during DQ, IQ, OQ, and PQ phases
- •Support FATs and SATs
- •Maintain the qualified condition of equipment
- •Plan and implement necessary requalifications
- •Perform periodic reviews of qualifications
- •Develop the qualification concept with updated standards and guidelines
- •Represent the department during audits and inspections
Languages
English – Business Fluent
Benefits
Flexible Working
- •Flexible working arrangements
Informal Culture
- •Open culture
- •Diverse workforce
Learning & Development
- •Wide range of training options
Retirement Plans
- •Competitive pension fund plan
Bonuses & Incentives
- •Annual bonus
- LonzaFull-timeOn-siteExperiencedVisp
- CH12 Lonza AG
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Senior Qualification Engineer(m/w/x)
The AI Job Search Engine
Description
In this role, you will take charge of the CQV strategy for a cutting-edge manufacturing site, managing qualification projects and ensuring compliance with the highest quality standards. Your expertise will shape the facility's operations while maintaining equipment qualifications and representing the department during audits.
Let AI find the perfect jobs for you!
Upload your CV and Nejo AI will find matching job offers for you.
Requirements
- •Master's/Bachelor's degree in mechanical engineering, pharmaceutical technology, medical technology, chemistry, process engineering, or similar
- •Sound knowledge and several years of experience in plant qualification in a GMP surrounding
- •Good understanding of GMP, technical and bioprocess understanding, quality and safety awareness
- •Proactive collaboration with Customer Delivery, QA, and IT Circles
Education
Work Experience
2 - 5 years
Tasks
- •Lead the CQV strategy for the new manufacturing site
- •Independently plan and manage qualification projects
- •Engage specialized external companies for qualifications
- •Supervise and check assignments from external companies
- •Conduct qualifications during DQ, IQ, OQ, and PQ phases
- •Support FATs and SATs
- •Maintain the qualified condition of equipment
- •Plan and implement necessary requalifications
- •Perform periodic reviews of qualifications
- •Develop the qualification concept with updated standards and guidelines
- •Represent the department during audits and inspections
Languages
English – Business Fluent
Benefits
Flexible Working
- •Flexible working arrangements
Informal Culture
- •Open culture
- •Diverse workforce
Learning & Development
- •Wide range of training options
Retirement Plans
- •Competitive pension fund plan
Bonuses & Incentives
- •Annual bonus
About the Company
ten23 health
Industry
Pharmaceuticals
Description
The company is a human-centric strategic partner for the pharmaceutical industry and biotech start-ups, focusing on the development and testing of medicines.
- Lonza
Qualification CQV Engineer(m/w/x)
Full-timeOn-siteExperiencedVisp - CH12 Lonza AG
(Senior) QA Qualification Specialist(m/w/x)
Full-timeOn-siteExperiencedVisp - Lonza
Senior QA Specialist - Qualification/Validation/EM (Environmental Monitoring)(m/w/x)
Full-timeOn-siteSeniorVisp - CH12 Lonza AG
CQV Engineer / Qualification & Validation Engineer(m/w/x)
Full-timeOn-siteExperiencedVisp - CH12 Lonza AG
Associate Director CQV Integrated Biologics(m/w/x)
Full-timeOn-siteSeniorVisp