Dein persönlicher KI-Karriere-Agent
Process Validation Expert(m/w/x)
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.
Anforderungen
- 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)
Aufgaben
- 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
Berufserfahrung
- 5 Jahre
Ausbildung
- Master-Abschluss
Sprachen
- Französisch – verhandlungssicher
- Englisch – verhandlungssicher
Benefits
Lockere Unternehmenskultur
- Culture of inclusion and belonging
Karriere- und Weiterentwicklung
- Opportunities for development and growth
Noch nicht perfekt?
- SMO Medtronic Europe SàrlVollzeitnur vor OrtSeniorLausanneab CHF 111.200 - 166.800 / Jahr
- SMO Medtronic Europe Sàrl
Senior Process Engineer(m/w/x)
Vollzeitnur vor OrtSeniorLausanneab CHF 111.200 - 166.800 / Jahr - SMO Medtronic Europe Sàrl
Quality Systems Specialist(m/w/x)
Vollzeitnur vor OrtBerufserfahrenLausanneab CHF 144.000 / Jahr - SMO Medtronic Europe Sàrl
Quality Systems Specialist(m/w/x)
Vollzeitnur vor OrtBerufserfahrenTolochenaz, Lausanneab CHF 144.000 / Jahr - SMO Medtronic Europe Sàrl
Intern Process Development Engineering(m/w/x)
VollzeitPraktikumnur vor OrtLausanneab CHF 2.000 - 2.500 / Monat
Process Validation Expert(m/w/x)
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.
Anforderungen
- 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)
Aufgaben
- 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
Berufserfahrung
- 5 Jahre
Ausbildung
- Master-Abschluss
Sprachen
- Französisch – verhandlungssicher
- Englisch – verhandlungssicher
Benefits
Lockere Unternehmenskultur
- Culture of inclusion and belonging
Karriere- und Weiterentwicklung
- Opportunities for development and growth
Über das Unternehmen
SUSONITY
Branche
Healthcare
Beschreibung
Das Unternehmen entwickelt Medikamente, intelligente Geräte und innovative Technologien in Therapiegebieten wie der Onkologie, Neurologie und Fruchtbarkeit.
Noch nicht perfekt?
- SMO Medtronic Europe Sàrl
Senior Process Engineer(m/w/x)
Vollzeitnur vor OrtSeniorLausanneab CHF 111.200 - 166.800 / Jahr - SMO Medtronic Europe Sàrl
Senior Process Engineer(m/w/x)
Vollzeitnur vor OrtSeniorLausanneab CHF 111.200 - 166.800 / Jahr - SMO Medtronic Europe Sàrl
Quality Systems Specialist(m/w/x)
Vollzeitnur vor OrtBerufserfahrenLausanneab CHF 144.000 / Jahr - SMO Medtronic Europe Sàrl
Quality Systems Specialist(m/w/x)
Vollzeitnur vor OrtBerufserfahrenTolochenaz, Lausanneab CHF 144.000 / Jahr - SMO Medtronic Europe Sàrl
Intern Process Development Engineering(m/w/x)
VollzeitPraktikumnur vor OrtLausanneab CHF 2.000 - 2.500 / Monat