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Pre-Fillable Syringe Engineer (m/w/d).

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  • categoria
    engineering
  • Contatto
    Luca Furler
  • riferimento
    19955

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For our client, an international pharmaceutical company based in Basel, we are looking for an Pre-Fillable Syringe Engineer.


The perfect candidate has minimum 5 years experience in drug delivery device development, pref. pre-filled syringes, in a GMP regulated environment. Experience with Quality System Regulation (QSR), Design Control or similar working practices is required and the person needs to have a sound knowledge of legislation, regulation, industry standards and guidance within the area of combination products and medical devices.


General Information:
  • Start date: 01.03.2024
  • Latest Start Date: 01.06.2024
  • Planned duration: unlimited
  • Workplace: Basel
  • Workload: 100%
  • Home Office: max. 40%
  • Team: 14 Team members
  • Working hours: Standard 

Tasks & Responsibilities:
 
  • Serving as primary packaging expert on technical development teams to provide the best-in-class containers and drug delivery devices for our medicines
  • Author design control documentation (Design Development Plans, User Requirements Specifications, Design Inputs, Design Outputs, Design Verification Plans and DHF creation/maintenance DHF), conformity assessments and risk management documentation
  • Application of theoretical engineering knowledge, to establish robust technical product requirements, and develop engineering design solutions to assure drug containers and devices maintain the required level of performance throughout the life of the product
  • Support project leader to successfully bring drug-device combination products and medical devices to the market
  • Apply knowledge of the regulatory landscape to ensure standard compliant designs (e.g. ISO 13485, 21CFR820, ISO14971 and 21 CFR 820.30)
  • The role will require considerable cross-functional interaction within the department and with partner functions including Device Quality, Device Regulatory, Global Product Strategy, and Pharmaceutical & Analytical Development, as well as with external suppliers

Must Haves:
  • University level education (engineering / science degree or related discipline)
  • At least 5 years proven track record in pharmaceutical, biomedical, material science or different GMP related field
  • At least 5 years experience within drug delivery device development
  • Experience of working in Quality System Regulation (QSR), Design Control or similar working practices
  • Sound knowledge of legislation, regulation, industry standards and guidance within the area of combination products and medical devices with experience with Health Authority interactions
  • Demonstrable knowledge of the following: drug delivery devices, primary packaging, drug container interactions, parenteral drug delivery
  • Demonstrable knowledge of the following: risk assessment, tolerance analysis, statistical techniques, process capability, manufacturing processes and transport studies and validation
  • Excellent command of English language and proficiency in German preferable
  • Excellent documentation, presentation and interpersonal communication skills
For our client, an international pharmaceutical company based in Basel, we are looking for an Pre-Fillable Syringe Engineer.


The perfect candidate has minimum 5 years experience in drug delivery device development, pref. pre-filled syringes, in a GMP regulated environment. Experience with Quality System Regulation (QSR), Design Control or similar working practices is required and the person needs to have a sound knowledge of legislation, regulation, industry standards and guidance within the area of combination products and medical devices.


General Information:
  • Start date: 01.03.2024
  • Latest Start Date: 01.06.2024
  • Planned duration: unlimited
  • Workplace: Basel
  • Workload: 100%
  • Home Office: max. 40%
  • Team: 14 Team members
  • Working hours: Standard 

Tasks & Responsibilities:
 
  • Serving as primary packaging expert on technical development teams to provide the best-in-class containers and drug delivery devices for our medicines
  • Author design control documentation (Design Development Plans, User Requirements Specifications, Design Inputs, Design Outputs, Design Verification Plans and DHF creation/maintenance DHF), conformity assessments and risk management documentation
  • Application of theoretical engineering knowledge, to establish robust technical product requirements, and develop engineering design solutions to assure drug containers and devices maintain the required level of performance throughout the life of the product
  • Support project leader to successfully bring drug-device combination products and medical devices to the market
  • Apply knowledge of the regulatory landscape to ensure standard compliant designs (e.g. ISO 13485, 21CFR820, ISO14971 and 21 CFR 820.30)
  • The role will require considerable cross-functional interaction within the department and with partner functions including Device Quality, Device Regulatory, Global Product Strategy, and Pharmaceutical & Analytical Development, as well as with external suppliers

Must Haves:
  • University level education (engineering / science degree or related discipline)
  • At least 5 years proven track record in pharmaceutical, biomedical, material science or different GMP related field
  • At least 5 years experience within drug delivery device development
  • Experience of working in Quality System Regulation (QSR), Design Control or similar working practices
  • Sound knowledge of legislation, regulation, industry standards and guidance within the area of combination products and medical devices with experience with Health Authority interactions
  • Demonstrable knowledge of the following: drug delivery devices, primary packaging, drug container interactions, parenteral drug delivery
  • Demonstrable knowledge of the following: risk assessment, tolerance analysis, statistical techniques, process capability, manufacturing processes and transport studies and validation
  • Excellent command of English language and proficiency in German preferable
  • Excellent documentation, presentation and interpersonal communication skills

contattaci.

saremo felici di rispondere alle tue domande in merito a questa posizione.

LF

Luca Furler

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