Thermo Fisher Scientific Inc.
Senior Requalification Engineer(m/w/x)
Full-timeOn-siteSenior
Lengnau
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THThermo Fisher Scientific
Senior QA Qualification and Validation Specialist(m/w/x)
Lengnau
Full-timeOn-siteSenior
Nejo AI Summary
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.
Requirements
- 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
Tasks
- 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
Work Experience
- approx. 4 - 6 years
Education
- Bachelor's degreeOR
- Master's degree
Languages
- English – Business Fluent
Tools & Technologies
- cGMP
- FDA regulations
- ISO
- GAMP5
- DQ/IQ/OQ/PQ
- Automation systems
- Computer system validation
- Quality management systems
Benefits
Competitive Pay
- Competitive remuneration
Career Advancement
- Career and development prospects
Informal Culture
- Exciting company culture
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of Thermo Fisher Scientific 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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THThermo Fisher Scientific
Senior QA Qualification and Validation Specialist(m/w/x)
Lengnau
Full-timeOn-siteSenior
Nejo AI Summary
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.
Requirements
- 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
Tasks
- 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
Work Experience
- approx. 4 - 6 years
Education
- Bachelor's degreeOR
- Master's degree
Languages
- English – Business Fluent
Tools & Technologies
- cGMP
- FDA regulations
- ISO
- GAMP5
- DQ/IQ/OQ/PQ
- Automation systems
- Computer system validation
- Quality management systems
Benefits
Competitive Pay
- Competitive remuneration
Career Advancement
- Career and development prospects
Informal Culture
- Exciting company culture
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of Thermo Fisher Scientific 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
Thermo Fisher Scientific
Industry
Pharmaceuticals
Description
The company enables customers to make the world healthier, cleaner, and safer through innovative scientific solutions.
Not a perfect match?
- Thermo Fisher Scientific Inc.
Senior Requalification Engineer(m/w/x)
Full-timeOn-siteSeniorLengnau - SIEGFRIED DiNAMIQS AG
QA Specialist(m/w/x)
Full-timeOn-siteSeniorSchlieren - Thermo Fisher Scientific
Senior Scientist, Material Qualification & Release (QC GMP)(m/w/x)
Full-timeOn-siteSeniorLengnau - Thermo Fisher Scientific Inc.
Sr. Electrical Engineer (German speaking)(m/w/x)
Full-timeOn-siteSeniorLengnau - HITACHI ENERGY LTD
Quality Specialist(m/w/x)
Full-timeOn-siteExperiencedWettingen