Thermo Fisher Scientific
Senior QA Qualification and Validation Specialist(m/w/x)
Full-timeOn-siteSenior
Lengnau
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THThermo Fisher Scientific Inc.
Senior Requalification Engineer(m/w/x)
Lengnau
Full-timeOn-siteSenior
Nejo AI Summary
Approving production and validation reports for compliance in a GMP-regulated cleanroom. 10 years experience with Bachelor's degree in engineering or related field, plus strict cleanroom adherence, required. Contributing to global health and safety standards.
Requirements
- Adherence to GMP Safety Standards
- Cleanroom adherence (no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair)
- Use of PPE (safety glasses, gowning, gloves, lab coat, ear plugs)
- Bachelor’s degree in Biotechnology, Quality, Mechanical, Manufacturing, Industrial Engineering, or related field
- 10 years experience with Bachelor's degree
- Master's degree + 3 years experience in engineering field (preferably pharmaceutical or chemical process industry)
- Functional knowledge of cGMPs and manufacturing operations in FDA regulated facility
- Experience in pharmaceutical industry for qualification & validation
- Experience in multi-cultural work environment
- Excellent verbal and written communication skills in English
- Preferably German or another European language skills
- Strong understanding of GMP standards and regulatory requirements
- Excellent technical writing skills with attention to detail
- Proficiency in PC applications, including MS Office
- Strong communication and interpersonal skills
- Certification in technical writing or quality management
- Experience with electronic documentation management systems (e.g., Documentum, TrackWise)
Tasks
- Prepare, review, and approve production reports.
- Prepare, review, and approve validation reports.
- Prepare, review, and approve audit reports.
- Prepare, review, and approve procedures and rationales.
- Prepare, review, and approve relevant documents.
- Evaluate new and existing regulations and trends.
- Prepare inspection and audit responses and reports.
- Perform gap analysis for efficiency improvements.
- Take appropriate actions based on gap analysis.
- Define GMP system requalification strategies with partners.
- Implement GMP system requalification strategies.
- Maintain the quality system.
- Complete practical requalification activities.
- Coordinate activities executed by external contractors.
- Execute routine and non-routine requalification/revalidation work orders.
- Document work orders in forms and OMX.
- Ensure documentation follows Good Documentation Practices.
- Participate in continuous improvement and technology development.
- Identify training needs.
- Develop training programs.
- Work safely and responsibly.
- Participate in calibration activities.
Work Experience
- 3 years
Education
- Bachelor's degreeOR
- Master's degree
Languages
- English – Business Fluent
- German – Basic
Tools & Technologies
- MS Office
- Documentum
- TrackWise
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of Thermo Fisher Scientific Inc. 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 Inc.
Senior Requalification Engineer(m/w/x)
Lengnau
Full-timeOn-siteSenior
Nejo AI Summary
Approving production and validation reports for compliance in a GMP-regulated cleanroom. 10 years experience with Bachelor's degree in engineering or related field, plus strict cleanroom adherence, required. Contributing to global health and safety standards.
Requirements
- Adherence to GMP Safety Standards
- Cleanroom adherence (no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair)
- Use of PPE (safety glasses, gowning, gloves, lab coat, ear plugs)
- Bachelor’s degree in Biotechnology, Quality, Mechanical, Manufacturing, Industrial Engineering, or related field
- 10 years experience with Bachelor's degree
- Master's degree + 3 years experience in engineering field (preferably pharmaceutical or chemical process industry)
- Functional knowledge of cGMPs and manufacturing operations in FDA regulated facility
- Experience in pharmaceutical industry for qualification & validation
- Experience in multi-cultural work environment
- Excellent verbal and written communication skills in English
- Preferably German or another European language skills
- Strong understanding of GMP standards and regulatory requirements
- Excellent technical writing skills with attention to detail
- Proficiency in PC applications, including MS Office
- Strong communication and interpersonal skills
- Certification in technical writing or quality management
- Experience with electronic documentation management systems (e.g., Documentum, TrackWise)
Tasks
- Prepare, review, and approve production reports.
- Prepare, review, and approve validation reports.
- Prepare, review, and approve audit reports.
- Prepare, review, and approve procedures and rationales.
- Prepare, review, and approve relevant documents.
- Evaluate new and existing regulations and trends.
- Prepare inspection and audit responses and reports.
- Perform gap analysis for efficiency improvements.
- Take appropriate actions based on gap analysis.
- Define GMP system requalification strategies with partners.
- Implement GMP system requalification strategies.
- Maintain the quality system.
- Complete practical requalification activities.
- Coordinate activities executed by external contractors.
- Execute routine and non-routine requalification/revalidation work orders.
- Document work orders in forms and OMX.
- Ensure documentation follows Good Documentation Practices.
- Participate in continuous improvement and technology development.
- Identify training needs.
- Develop training programs.
- Work safely and responsibly.
- Participate in calibration activities.
Work Experience
- 3 years
Education
- Bachelor's degreeOR
- Master's degree
Languages
- English – Business Fluent
- German – Basic
Tools & Technologies
- MS Office
- Documentum
- TrackWise
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of Thermo Fisher Scientific Inc. 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 Inc.
Industry
Science
Description
The company is a world leader in serving science, enabling customers to make the world healthier, cleaner, and safer.
Not a perfect match?
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