Dein persönlicher KI-Karriere-Agent
Coordinator of Environmental Monitoring/Utilities (EM)(m/w/x)
Overseeing facility environment compliance for water, gas, and critical areas at a company enriching lives in Healthcare, Life Science, and Electronics. Master's or PhD in Microbiology, with significant pharma/biopharma industry experience, required. On-site presence expected.
Anforderungen
- Master's or PhD in Microbiology or equivalent
- Significant experience in similar role, preferably in pharmaceutical/biopharmaceutical industry (GLP/GMP labs)
- In-depth knowledge of microbiology industry regulations and standards
- Experience in training personnel and managing outsourced activities (preferred)
- Proven experience in test method validation
- Proficiency in LIMS and SAP
- Flexibility and adaptability in high-growth environment
- Excellent verbal and written communication skills in English
- Proactive approach to problem-solving
Aufgaben
- Oversee environmental monitoring for water, gas, and critical areas.
- Ensure program compliance with regulatory and quality standards.
- Conduct risk assessments for quality events.
- Analyze impacts of quality events.
- Provide strategic recommendations for risk mitigation.
- Provide scientific guidance on testing methods.
- Ensure testing method effectiveness.
- Align testing methods with industry best practices.
- Write SOPs and departmental protocols.
- Revise SOPs and departmental protocols.
- Review SOPs and departmental reports.
- Perform quality reviews for microbiological data.
- Perform quality reviews for environmental monitoring data.
- Ensure accurate trending of data.
- Establish and maintain microbiological control programs.
- Establish and maintain contamination control programs.
- Oversee endotoxin and bioburden testing.
- Collaborate with management on regulatory inspections.
- Collaborate with management on audits.
- Ensure compliance with GMP requirements.
- Act as microbiological SME during audits.
- Drive continuous improvement in microbiological processes.
Berufserfahrung
- ca. 1 - 4 Jahre
Ausbildung
- Master-Abschluss
Sprachen
- Englisch – verhandlungssicher
Tools & Technologien
- LIMS
- SAP
Noch nicht perfekt?
- SMO Medtronic Europe SàrlVollzeitnur vor OrtBerufserfahrenLausanne
- SMO Medtronic Europe Sàrl
Calibration & Maintenance Tech II(m/w/x)
Vollzeitnur vor OrtBerufserfahrenLausanne - SMO Medtronic Europe Sàrl
Senior Process Engineer(m/w/x)
Vollzeitnur vor OrtSeniorLausanneab CHF 111.200 - 166.800 / Jahr - SMO Medtronic Europe Sàrl
Associate Calibration Engineer(m/w/x)
Vollzeitnur vor OrtBerufserfahrenLausanneab CHF 123.480 / Jahr - SUSONITY
Internship - QC Microbiology(m/w/x)
VollzeitPraktikumnur vor OrtCorsier-sur-Vevey
Coordinator of Environmental Monitoring/Utilities (EM)(m/w/x)
Overseeing facility environment compliance for water, gas, and critical areas at a company enriching lives in Healthcare, Life Science, and Electronics. Master's or PhD in Microbiology, with significant pharma/biopharma industry experience, required. On-site presence expected.
Anforderungen
- Master's or PhD in Microbiology or equivalent
- Significant experience in similar role, preferably in pharmaceutical/biopharmaceutical industry (GLP/GMP labs)
- In-depth knowledge of microbiology industry regulations and standards
- Experience in training personnel and managing outsourced activities (preferred)
- Proven experience in test method validation
- Proficiency in LIMS and SAP
- Flexibility and adaptability in high-growth environment
- Excellent verbal and written communication skills in English
- Proactive approach to problem-solving
Aufgaben
- Oversee environmental monitoring for water, gas, and critical areas.
- Ensure program compliance with regulatory and quality standards.
- Conduct risk assessments for quality events.
- Analyze impacts of quality events.
- Provide strategic recommendations for risk mitigation.
- Provide scientific guidance on testing methods.
- Ensure testing method effectiveness.
- Align testing methods with industry best practices.
- Write SOPs and departmental protocols.
- Revise SOPs and departmental protocols.
- Review SOPs and departmental reports.
- Perform quality reviews for microbiological data.
- Perform quality reviews for environmental monitoring data.
- Ensure accurate trending of data.
- Establish and maintain microbiological control programs.
- Establish and maintain contamination control programs.
- Oversee endotoxin and bioburden testing.
- Collaborate with management on regulatory inspections.
- Collaborate with management on audits.
- Ensure compliance with GMP requirements.
- Act as microbiological SME during audits.
- Drive continuous improvement in microbiological processes.
Berufserfahrung
- ca. 1 - 4 Jahre
Ausbildung
- Master-Abschluss
Sprachen
- Englisch – verhandlungssicher
Tools & Technologien
- LIMS
- SAP
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
Calibration & Maintenance Tech II(m/w/x)
Vollzeitnur vor OrtBerufserfahrenLausanne - SMO Medtronic Europe Sàrl
Calibration & Maintenance Tech II(m/w/x)
Vollzeitnur vor OrtBerufserfahrenLausanne - SMO Medtronic Europe Sàrl
Senior Process Engineer(m/w/x)
Vollzeitnur vor OrtSeniorLausanneab CHF 111.200 - 166.800 / Jahr - SMO Medtronic Europe Sàrl
Associate Calibration Engineer(m/w/x)
Vollzeitnur vor OrtBerufserfahrenLausanneab CHF 123.480 / Jahr - SUSONITY
Internship - QC Microbiology(m/w/x)
VollzeitPraktikumnur vor OrtCorsier-sur-Vevey