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Senior Engineer (Drug Delivery Lead)(m/w/x)
Project leadership for drug delivery device packaging and medical devices at biotherapeutics leader. 7+ years in drug delivery device development within pharma or highly regulated environment required. Global cross-functional team collaboration in a matrix organization.
Anforderungen
- University level education; ideally a Masters or PhD in Biomedical Engineering, Electrical or Mechanical Engineering or in a related field
- Minimum of 7 years in drug delivery device development with relevant pharma industry experience or other highly regulated environment
- Background in development of combination products for respiratory drug delivery
- Experience in project leadership in a matrix organization
- Strong organizational and communication skills
- Experience with regulatory and quality standards and generation of documentation for regulatory agencies
Aufgaben
- Plan and execute projects for evaluating and improving packaging materials and medical devices
- Deliver projects on time, within quality standards and budget constraints
- Collaborate with global cross-functional teams and external partners
- Lead coordination of activities and information across functions
- Apply expertise in Design Controls and Risk Management standards
- Compile and maintain Design History Files and support design verification
- Deliver submission-ready packages for regulatory bodies
- Utilize engineering tools for robust design and device limitation analysis
Berufserfahrung
- 7 Jahre
Ausbildung
- Bachelor-AbschlussODER
- Master-Abschluss
Sprachen
- Englisch – verhandlungssicher
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Senior Engineer (Drug Delivery Lead)(m/w/x)
Project leadership for drug delivery device packaging and medical devices at biotherapeutics leader. 7+ years in drug delivery device development within pharma or highly regulated environment required. Global cross-functional team collaboration in a matrix organization.
Anforderungen
- University level education; ideally a Masters or PhD in Biomedical Engineering, Electrical or Mechanical Engineering or in a related field
- Minimum of 7 years in drug delivery device development with relevant pharma industry experience or other highly regulated environment
- Background in development of combination products for respiratory drug delivery
- Experience in project leadership in a matrix organization
- Strong organizational and communication skills
- Experience with regulatory and quality standards and generation of documentation for regulatory agencies
Aufgaben
- Plan and execute projects for evaluating and improving packaging materials and medical devices
- Deliver projects on time, within quality standards and budget constraints
- Collaborate with global cross-functional teams and external partners
- Lead coordination of activities and information across functions
- Apply expertise in Design Controls and Risk Management standards
- Compile and maintain Design History Files and support design verification
- Deliver submission-ready packages for regulatory bodies
- Utilize engineering tools for robust design and device limitation analysis
Berufserfahrung
- 7 Jahre
Ausbildung
- Bachelor-AbschlussODER
- Master-Abschluss
Sprachen
- Englisch – verhandlungssicher
Über das Unternehmen
CSL Behring
Branche
Pharmaceuticals
Beschreibung
Das Unternehmen ist ein globaler Marktführer in der Biotherapeutik, der innovative Therapien für Patienten mit immunologischen, hämatologischen, kardiovaskulären und anderen Erkrankungen entwickelt.
Noch nicht perfekt?
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