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Managing asset lifecycle and system qualification for new constructions and existing systems in active pharmaceutical ingredient (API) manufacturing. BSc or technical education in mechanical/plant engineering and several years API manufacturing experience required. Relocation assistance provided.
Requirements
- BSc or completed technical education in mechanical, plant engineering, EMR or related field
- Several years of experience in active pharmaceutical ingredient (API) manufacturing under GMP
- Good knowledge/experience in GMP
- Several years of experience in qualification
- Enjoyment in creating and maintaining qualification documentation with high standards of accuracy and cleanliness
- Very good PC skills (MS Office / SAP / DMS / COMOS)
- Fluency in German and English or willingness to learn one of the two languages
Tasks
- Manage asset life cycle for existing systems regarding qualification
- Oversee system qualification for new constructions and expansions
- Optimize existing systems before GMP production
- Coordinate technical change management
- Support the qualification lead in all aspects
- Assist Capex projects and the engineering team during project phases
- Coordinate interfaces between engineering, commissioning, and qualification
- Represent qualification during audits and inspections
- Review and finalize qualification activities
Work Experience
- approx. 1 - 4 years
Education
- Vocational certificationOR
- Bachelor's degree
Languages
- German – Business Fluent
- English – Business Fluent
Tools & Technologies
- MS Office
- SAP
- DMS
- COMOS
Benefits
Career Advancement
- Agile career
Informal Culture
- Dynamic work culture
- Inclusive workplace
Purpose-Driven Work
- Ethical workplace
Other Benefits
- Relocation assistance
Not a perfect match?
- CH12 Lonza AGFull-timeOn-siteExperiencedVisp
- CH12 Lonza AG
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(Senior) QA Qualification Specialist(m/w/x)
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Managing asset lifecycle and system qualification for new constructions and existing systems in active pharmaceutical ingredient (API) manufacturing. BSc or technical education in mechanical/plant engineering and several years API manufacturing experience required. Relocation assistance provided.
Requirements
- BSc or completed technical education in mechanical, plant engineering, EMR or related field
- Several years of experience in active pharmaceutical ingredient (API) manufacturing under GMP
- Good knowledge/experience in GMP
- Several years of experience in qualification
- Enjoyment in creating and maintaining qualification documentation with high standards of accuracy and cleanliness
- Very good PC skills (MS Office / SAP / DMS / COMOS)
- Fluency in German and English or willingness to learn one of the two languages
Tasks
- Manage asset life cycle for existing systems regarding qualification
- Oversee system qualification for new constructions and expansions
- Optimize existing systems before GMP production
- Coordinate technical change management
- Support the qualification lead in all aspects
- Assist Capex projects and the engineering team during project phases
- Coordinate interfaces between engineering, commissioning, and qualification
- Represent qualification during audits and inspections
- Review and finalize qualification activities
Work Experience
- approx. 1 - 4 years
Education
- Vocational certificationOR
- Bachelor's degree
Languages
- German – Business Fluent
- English – Business Fluent
Tools & Technologies
- MS Office
- SAP
- DMS
- COMOS
Benefits
Career Advancement
- Agile career
Informal Culture
- Dynamic work culture
- Inclusive workplace
Purpose-Driven Work
- Ethical workplace
Other Benefits
- Relocation assistance
About the Company
Lonza
Industry
Healthcare
Description
Lonza is a global leader in life sciences, committed to improving lives through innovative solutions and ethical practices.
Not a perfect match?
- CH12 Lonza AG
CQV Engineer / Qualification & Validation Engineer(m/w/x)
Full-timeOn-siteExperiencedVisp - CH12 Lonza AG
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Qualifizierungsspezialist CQV(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)
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