Thermo Fisher Scientific Inc.
Senior Requalification Engineer(m/w/x)
Vollzeitnur vor OrtSenior
Lengnau
Neuer Job?Nejo!
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THThermo Fisher Scientific
Senior QA Qualification and Validation Specialist(m/w/x)
Lengnau
VollzeitVor OrtSenior
Nejo KI-Zusammenfassung
Overseeing GMP-compliant commissioning and qualification for production facilities and equipment at scientific solutions provider. Deep cGMP, FDA, and industry standards knowledge with commissioning/qualification protocol experience required. Work in mission-driven scientific solutions environment.
Anforderungen
- Degree in Engineering, Life Science, or equivalent
- Knowledge of cGMP, FDA, and industry standards
- Experience with commissioning and qualification protocols
- Proficiency in risk assessment and gap analysis
- Strong data analysis and problem-solving capabilities
- Clear verbal and written communication skills
- Knowledge of calibration and metrology principles
- Experience with automation and computer validation
- Effective interpersonal skills and team collaboration
- Experience with quality management systems
- Experience in quality review of records
Aufgaben
- Oversee GMP-compliant commissioning and qualification for facilities and equipment
- Collaborate with Engineering Services to prepare systems for commercial production
- Assess and manage issues arising during commissioning and qualification
- Improve quality standards within assigned systems and production areas
- Share knowledge and contribute to continuous improvement initiatives
- Act as the QA representative within qualification teams
- Review and approve commissioning and qualification documentation
- Assess project-related deviations and open items
- Update SOPs and work instructions for qualification activities
Berufserfahrung
- ca. 4 - 6 Jahre
Ausbildung
- Bachelor-AbschlussODER
- Master-Abschluss
Sprachen
- Englisch – verhandlungssicher
Tools & Technologien
- cGMP
- FDA regulations
- ISO
- GAMP5
- DQ/IQ/OQ/PQ
- Automation systems
- Computer system validation
- Quality management systems
Benefits
Attraktive Vergütung
- Competitive remuneration
Karriere- und Weiterentwicklung
- Career and development prospects
Lockere Unternehmenskultur
- Exciting company culture
Die Originalanzeige dieses Stellenangebotes in der aktuellsten Version findest du hier. Nejo hat diesen Job automatisch von der Website des Unternehmens Thermo Fisher Scientific erfasst und die Informationen auf Nejo mit Hilfe von KI für dich aufbereitet. Trotz sorgfältiger Analyse können einzelne Informationen unvollständig oder ungenau sein. Bitte prüfe immer alle Angaben in der Originalanzeige! Inhalte und Urheberrechte der Originalanzeige liegen beim ausschreibenden Unternehmen.
Noch nicht perfekt?
- SIEGFRIED DiNAMIQS AG
QA Specialist(m/w/x)
Vollzeitnur vor OrtSeniorSchlieren - Thermo Fisher Scientific
Senior Scientist, Material Qualification & Release (QC GMP)(m/w/x)
Vollzeitnur vor OrtSeniorLengnau - Thermo Fisher Scientific Inc.
Sr. Electrical Engineer (German speaking)(m/w/x)
Vollzeitnur vor OrtSeniorLengnau - HITACHI ENERGY LTD
Quality Specialist(m/w/x)
Vollzeitnur vor OrtBerufserfahrenWettingen
THThermo Fisher Scientific
Senior QA Qualification and Validation Specialist(m/w/x)
Lengnau
VollzeitVor OrtSenior
Nejo KI-Zusammenfassung
Overseeing GMP-compliant commissioning and qualification for production facilities and equipment at scientific solutions provider. Deep cGMP, FDA, and industry standards knowledge with commissioning/qualification protocol experience required. Work in mission-driven scientific solutions environment.
Anforderungen
- Degree in Engineering, Life Science, or equivalent
- Knowledge of cGMP, FDA, and industry standards
- Experience with commissioning and qualification protocols
- Proficiency in risk assessment and gap analysis
- Strong data analysis and problem-solving capabilities
- Clear verbal and written communication skills
- Knowledge of calibration and metrology principles
- Experience with automation and computer validation
- Effective interpersonal skills and team collaboration
- Experience with quality management systems
- Experience in quality review of records
Aufgaben
- Oversee GMP-compliant commissioning and qualification for facilities and equipment
- Collaborate with Engineering Services to prepare systems for commercial production
- Assess and manage issues arising during commissioning and qualification
- Improve quality standards within assigned systems and production areas
- Share knowledge and contribute to continuous improvement initiatives
- Act as the QA representative within qualification teams
- Review and approve commissioning and qualification documentation
- Assess project-related deviations and open items
- Update SOPs and work instructions for qualification activities
Berufserfahrung
- ca. 4 - 6 Jahre
Ausbildung
- Bachelor-AbschlussODER
- Master-Abschluss
Sprachen
- Englisch – verhandlungssicher
Tools & Technologien
- cGMP
- FDA regulations
- ISO
- GAMP5
- DQ/IQ/OQ/PQ
- Automation systems
- Computer system validation
- Quality management systems
Benefits
Attraktive Vergütung
- Competitive remuneration
Karriere- und Weiterentwicklung
- Career and development prospects
Lockere Unternehmenskultur
- Exciting company culture
Die Originalanzeige dieses Stellenangebotes in der aktuellsten Version findest du hier. Nejo hat diesen Job automatisch von der Website des Unternehmens Thermo Fisher Scientific erfasst und die Informationen auf Nejo mit Hilfe von KI für dich aufbereitet. Trotz sorgfältiger Analyse können einzelne Informationen unvollständig oder ungenau sein. Bitte prüfe immer alle Angaben in der Originalanzeige! Inhalte und Urheberrechte der Originalanzeige liegen beim ausschreibenden Unternehmen.
Über das Unternehmen
Thermo Fisher Scientific
Branche
Pharmaceuticals
Beschreibung
The company enables customers to make the world healthier, cleaner, and safer through innovative scientific solutions.
Noch nicht perfekt?
- Thermo Fisher Scientific Inc.
Senior Requalification Engineer(m/w/x)
Vollzeitnur vor OrtSeniorLengnau - SIEGFRIED DiNAMIQS AG
QA Specialist(m/w/x)
Vollzeitnur vor OrtSeniorSchlieren - Thermo Fisher Scientific
Senior Scientist, Material Qualification & Release (QC GMP)(m/w/x)
Vollzeitnur vor OrtSeniorLengnau - Thermo Fisher Scientific Inc.
Sr. Electrical Engineer (German speaking)(m/w/x)
Vollzeitnur vor OrtSeniorLengnau - HITACHI ENERGY LTD
Quality Specialist(m/w/x)
Vollzeitnur vor OrtBerufserfahrenWettingen