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Process validation for NPI, TT, and process changes in Life Science and Healthcare. 5+ years biotech experience, including Drug Substance processes, required. 4-day work week, 6 weeks vacation.
Requirements
- MSc in Biotechnology, Life Sciences, or (Bio)Chemistry, or equivalent degree
- At least 5 years of professional experience in biotechnology
- Demonstrated experience in process validation
- Strong experience in Drug Substance processes (asset)
- Strong analytical capabilities
- Strong synthesis capabilities
- Excellent writing skills
- Proficiency with GMP/GDP
- Good knowledge of health authority requirements
- Organization
- Persistence
- Resilience
- Collaborative mindset
- Ability to work well in a team
- Ability to work independently and autonomously
- Very good communication skills
- Aptitude for digital tools
- Interest in statistical analyses
- Fluent French (spoken and written)
- Fluent English (spoken and written)
Tasks
- Define validation strategies for NPI, TT, and process changes
- Identify risks and technical choices for project teams
- Coordinate on-site process validation activities
- Prepare required validation documents and plans
- Train production teams on validation protocols
- Supervise execution of validation protocols
- Manage data and documentation using quality systems
- Collect and compile production data
- Interpret validation test results
- Manage deviations and validation investigations
- Update validation procedures and standards
- Promote integrity and professional ethics
- Ensure compliance with legal and regulatory directives
Work Experience
- 5 years
Education
- Master's degree
Languages
- French – Business Fluent
- English – Business Fluent
Benefits
Informal Culture
- Culture of inclusion and belonging
Career Advancement
- Opportunities for development and growth
Not a perfect match?
- SMO Medtronic Europe SàrlFull-timeOn-siteSeniorLausannefrom CHF 111,200 - 166,800 / year
- SMO Medtronic Europe Sàrl
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Process validation for NPI, TT, and process changes in Life Science and Healthcare. 5+ years biotech experience, including Drug Substance processes, required. 4-day work week, 6 weeks vacation.
Requirements
- MSc in Biotechnology, Life Sciences, or (Bio)Chemistry, or equivalent degree
- At least 5 years of professional experience in biotechnology
- Demonstrated experience in process validation
- Strong experience in Drug Substance processes (asset)
- Strong analytical capabilities
- Strong synthesis capabilities
- Excellent writing skills
- Proficiency with GMP/GDP
- Good knowledge of health authority requirements
- Organization
- Persistence
- Resilience
- Collaborative mindset
- Ability to work well in a team
- Ability to work independently and autonomously
- Very good communication skills
- Aptitude for digital tools
- Interest in statistical analyses
- Fluent French (spoken and written)
- Fluent English (spoken and written)
Tasks
- Define validation strategies for NPI, TT, and process changes
- Identify risks and technical choices for project teams
- Coordinate on-site process validation activities
- Prepare required validation documents and plans
- Train production teams on validation protocols
- Supervise execution of validation protocols
- Manage data and documentation using quality systems
- Collect and compile production data
- Interpret validation test results
- Manage deviations and validation investigations
- Update validation procedures and standards
- Promote integrity and professional ethics
- Ensure compliance with legal and regulatory directives
Work Experience
- 5 years
Education
- Master's degree
Languages
- French – Business Fluent
- English – Business Fluent
Benefits
Informal Culture
- Culture of inclusion and belonging
Career Advancement
- Opportunities for development and growth
About the Company
SUSONITY
Industry
Healthcare
Description
Das Unternehmen entwickelt Medikamente, intelligente Geräte und innovative Technologien in Therapiegebieten wie der Onkologie, Neurologie und Fruchtbarkeit.
Not a perfect match?
- SMO Medtronic Europe Sàrl
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Full-timeOn-siteSeniorLausannefrom CHF 111,200 - 166,800 / year - SMO Medtronic Europe Sàrl
Quality Systems Specialist(m/w/x)
Full-timeOn-siteExperiencedLausannefrom CHF 144,000 / year - SMO Medtronic Europe Sàrl
Quality Systems Specialist(m/w/x)
Full-timeOn-siteExperiencedTolochenaz, Lausannefrom CHF 144,000 / year - SMO Medtronic Europe Sàrl
Intern Process Development Engineering(m/w/x)
Full-timeInternshipOn-siteLausannefrom CHF 2,000 - 2,500 / month