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Pre-Fillable Syringe Engineer (897120-MST)

CTC Resourcing Solutions

 
Basel area
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Founded in 1997 and headquartered in Basel, Switzerland, CTC is a specialist life-sciences recruitment organisation. We place specialist talent into contract and permanent positions in the pharmaceutical, biotech, medical devices and CRO industries.

An in-depth experience in life-sciences recruitment combined with an established and extensive local network means that CTC offers clients and candidates the “Gold standard” in recruitment services. With an expertise honed over many years at the cutting-edge of the life-sciences industry, we help companies find people and we help people find companies.

Pre-Fillable Syringe Engineer (897120-MST)

Our client is a pioneer in Drug Discovery and Development. As the world`s largest R&D spender in the pharmaceutical domain, they work in a vast number of drug discovery & therapeutic areas and are highly recognized internationally. A leader in the field of manufacturing and selling of several drugs with treatment of Cancer. We are currently looking for an enthusiastic Pre-Fillable Syringe Engineer for a 12-monthscontract to be based in Basel.

The department is responsible for the development and support of drug delivery devices for the product portfolio. The activities span from a range of engineering disciplines, from the requirements definition phase through to commercialization and marketed product support. We are looking for a Pre-Fillable Syringe Engineer to support the development and maintenance of drug delivery devices (e.g. Prefilled Syringes with Needle Safety Devices, Autoinjectors, high-volume Patch-injectors).

Main 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)

Qualifications and Experience:

  • Relevant Swiss working/residency permit or Swiss/EU-Citizenship required;
  • University level education (engineering / science degree or related discipline) and minimum 5 years proven track record in pharmaceutical, biomedical, material science or a related field;
  • Drug delivery device development with experience of working in pharma or other closely-regulated environment, under current Good Practice (cGxP), Quality System Regulation (QSR), Design Control or similar working practice;
  • 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, 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.

Adresse

CTC Clinical Trial Consulting AG
Mr CTC Resourcing Solutions
Münchensteinerstrasse 41
4052 Basel
+41 61 695 88 66

Site web http://www.ctcresourcing.com

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