Roche Diagnostics Int. AG
Internship in MSAT Process Engineering - Digitalization & RAW2 Focus (m/w/x)
VollzeitPraktikumnur vor Ort
Risch-Rotkreuz
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Leading GMP deviation investigations and CAPA definition for biologics drug substance manufacturing. Proven ability to solve complex problems with minimal guidance required. Early-stage clinical pipeline support, technology innovation hub.
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Anforderungen
- Bachelor's or Master's degree in scientific, engineering, or technical discipline
- Solid experience in GMP-regulated biologics manufacturing, quality systems, compliance, technical operations, or related area
- Proven ability to solve complex problems and lead investigations with minimal guidance
- Strong knowledge of GMP expectations, quality systems, documentation standards, and risk-based decision-making
- Experience working cross-functionally with Manufacturing, Quality, Engineering, and MSAT
- Ability to lead projects or workstreams and influence stakeholders
- Strong communication skills in German and English
- Compliance Activities, Compliance Monitoring, Deviation Management, Good Manufacturing Practices (GMP), Identifying Risks, Process Optimization, Quality Compliance, Regulatory Audits, Risk Assessments, Risk Avoidance, Standards Compliance
- Cross-Functional Teamwork, Quality Risk Management
Aufgaben
- Lead resolution of complex GMP deviation records, investigations, and CAPAs
- Perform impact assessments for GMP deviations
- Apply risk-based thinking to analyze non-standard issues
- Lead root cause analysis and CAPA definition
- Escalate complex or high-risk topics with recommendations
- Manage GMP product-related change controls and risk records
- Apply quality risk management principles to manufacturing topics
- Provide input into risk assessments and change strategies
- Ensure documentation tasks and compliance deliverables are controlled
- Provide first-line compliance support for production troubleshooting
- Support Manufacturing teams in resolving operational issues
- Translate partner and customer needs into compliant solutions
- Prepare options, recommendations, and risk-based assessments for decisions
- Support monitoring and tracking of quality and compliance KPIs
- Use data analysis to identify risks and improvement opportunities
- Drive continuous improvement using operational excellence tools
- Identify and implement improvements within your area
- Support ongoing inspection readiness for GMP documentation
- Participate in preparation for audits and inspections
- Represent your functional area during audits as SME
- Strengthen inspection-ready behaviors within assigned areas
- Perform GMP impact assessments for facility and equipment changes
- Collaborate with Engineering to ensure compliant project execution
- Provide compliance input to facility topics impacting operations
- Lead compliance or quality improvement projects
- Act as project lead, coordinating contributors and tracking milestones
- Build strong working relationships across teams
- Coach and guide junior team members
- Support knowledge sharing across the group
Berufserfahrung
ca. 4 - 6 Jahre
Ausbildung
Master-Abschluss
Sprachen
Deutsch – fließend
Englisch – fließend
Tools & Technologien
GMPMSAT
Von Nejo automatisch aufbereitet
Nejo hat diesen Job automatisch von der Website des Unternehmens Merck & Co., Inc. erfasst und die Informationen auf Nejo mit Hilfe von KI für dich aufbereitet. Trotz sorgfältiger Analyse können einzelne Informationen unvollständig oder ungenau sein. Bitte prüfe immer alle Angaben in der Originalanzeige! Inhalte und Urheberrechte der Originalanzeige liegen beim ausschreibenden Unternehmen.
Zur Originalanzeige bei Merck & Co., Inc.Über das Unternehmen
ME
PharmaceuticalsLuzern
Das Unternehmen agiert als weltweit zuverlässiger Hersteller und Lieferant von Biopharmazeutika und beliefert Kunden und Patienten mit qualitativ hochwertigen Produkten.
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