Die KI-Suchmaschine für Jobs
Validation and commissioning of critical computerized systems for new construction and expansion projects in the life sciences industry. Significant experience in regulated environments for computerized system validation required, Delta-V knowledge preferred. Work across multiple project sites.
Anforderungen
- Bachelor, Master, Diploma from a technical school, university of applied sciences, or equivalent experience
- Significant experience in a regulated environment with regard to Computerized System Validation (CSV)
- Good knowledge of Microsoft Office and Delta-V
- Knowledge of KNEAT, COMOS, DMS, TrackWise, and SAP
- Proficiency in English, with German language skills being advantageous
Aufgaben
- Generate and execute validation for computerized systems
- Follow planning and implementation of CSV activities
- Prepare commissioning and validation documents for new systems
- Supervise conversion, expansion, and new construction projects
- Conduct CSV activities for critical systems in new construction
- Provide SLC support for all systems post debut
- Supervise deviations, changes, and CAPAs
- Coordinate CSV executions with internal groups and external providers
- Present CSV documents during audits and inspections
- Schedule and report CSV activities
- Align CSV strategy with QA CSV for all Biologics scope
- Contribute to the review and continuous improvement of CSV documents
Berufserfahrung
- ca. 4 - 6 Jahre
Ausbildung
- Bachelor-Abschluss
Sprachen
- Englisch – verhandlungssicher
- Deutsch – Grundkenntnisse
Tools & Technologien
- Microsoft Office
- Delta-V
- KNEAT
- COMOS
- DMS
- TrackWise
- SAP
Noch nicht perfekt?
- CH12 Lonza AGVollzeitnur vor OrtJuniorVisp
- Lonza
Team Lead CSV Biologics(m/w/x)
Vollzeitnur vor OrtSeniorVisp - CH12 Lonza AG
CQV Engineer / Qualification & Validation Engineer(m/w/x)
Vollzeitnur vor OrtBerufserfahrenVisp - Lonza
Functional Lead QA CSV(m/w/x)
Vollzeitnur vor OrtSeniorVisp - Lonza
Qualification CQV Engineer(m/w/x)
Vollzeitnur vor OrtBerufserfahrenVisp
Validation and commissioning of critical computerized systems for new construction and expansion projects in the life sciences industry. Significant experience in regulated environments for computerized system validation required, Delta-V knowledge preferred. Work across multiple project sites.
Anforderungen
- Bachelor, Master, Diploma from a technical school, university of applied sciences, or equivalent experience
- Significant experience in a regulated environment with regard to Computerized System Validation (CSV)
- Good knowledge of Microsoft Office and Delta-V
- Knowledge of KNEAT, COMOS, DMS, TrackWise, and SAP
- Proficiency in English, with German language skills being advantageous
Aufgaben
- Generate and execute validation for computerized systems
- Follow planning and implementation of CSV activities
- Prepare commissioning and validation documents for new systems
- Supervise conversion, expansion, and new construction projects
- Conduct CSV activities for critical systems in new construction
- Provide SLC support for all systems post debut
- Supervise deviations, changes, and CAPAs
- Coordinate CSV executions with internal groups and external providers
- Present CSV documents during audits and inspections
- Schedule and report CSV activities
- Align CSV strategy with QA CSV for all Biologics scope
- Contribute to the review and continuous improvement of CSV documents
Berufserfahrung
- ca. 4 - 6 Jahre
Ausbildung
- Bachelor-Abschluss
Sprachen
- Englisch – verhandlungssicher
- Deutsch – Grundkenntnisse
Tools & Technologien
- Microsoft Office
- Delta-V
- KNEAT
- COMOS
- DMS
- TrackWise
- SAP
Über das Unternehmen
CH12 Lonza AG
Branche
Healthcare
Beschreibung
The company is a global leader in life sciences, dedicated to improving lives through innovative solutions.
Noch nicht perfekt?
- CH12 Lonza AG
Junior CSV Engineer(m/w/x)
Vollzeitnur vor OrtJuniorVisp - Lonza
Team Lead CSV Biologics(m/w/x)
Vollzeitnur vor OrtSeniorVisp - CH12 Lonza AG
CQV Engineer / Qualification & Validation Engineer(m/w/x)
Vollzeitnur vor OrtBerufserfahrenVisp - Lonza
Functional Lead QA CSV(m/w/x)
Vollzeitnur vor OrtSeniorVisp - Lonza
Qualification CQV Engineer(m/w/x)
Vollzeitnur vor OrtBerufserfahrenVisp