sterility assurance specialist in Solothurn

Lucie Nasshan, Basel Professionals Health Care & Life Sciences
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job details

Life Sciences
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lucie nasshan, basel professionals health care & life sciences
058 201 55 50
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job description

Randstad Professionals is currently looking for a Sterility Assurance Specialist who will be assigned an interesting challenge for a major client based in Solothurn.

This contract is a great opportunity to join a major client, global group focusing on the Healthcare sector (Medical device, Pharma/vaccines, Consumer health).

The initial assignment will start ASAP ( december 2018) and will last until December 2019.


  • Review, maintain and develop procedures tools and methodologies to cover all Sterility Assurance programs

  • Responsible for the European Sterility Assurance activities.

  • Ensure compliancy to new MDR

  • Ensures compliance to the applicable Medical Device Directive (MDD), ISO 13485, ISO 14971, ISO 9001 and FDA (QSR) regulations as they apply to sterilization. Additionally to other applicable Cleaning and Sterilization ISO and EN standards (esp. EN ISO EN ISO 15883, EN ISO 17665, EN ISO 17664), AAMI standards/reports (e.g. AAMI TIR 12 and 30) and other guidance documents as required.

  • Maintain knowledge of FDA & ISO sterilization guidelines

  • Evaluate gamma-, ethylene oxide- and moist heat- sterilization processes for existing products and compliancy to new MDR requirements.

  • Develop and evaluate cleaning, disinfection and steam sterilization processes for existing and new products.

  • Review and evaluate reprocessing strategies and processes for new MDR

  • Validate all microbial aspects of existing products

  • Ensure the development and implementation of harmonized practices/procedures.

  • Review external validation protocols and reports to ensure Synthes and regulatory requirements are met.

  • Implement the microbial assurance aspects of the Quality System.

  • Review and analyze medical device drawings

  • Actively support our compliance program and related initiates or activities.

Candidates’s profile :

  • A Bachelor of Science Degree is required. A Master of Science or PhD is preferred.

  • Minimum of 5 years experiences in support of medical devices delivery, biology, pharmaceutical, or similar regulated industry.

  • Proven knowledge of FDA and MDD GMP requirements or standards regarding medical Devices.

  • Experience with GMP environments, particularly sterilization processes, microbiological testing.

  • Well known with critical design features for clinical reprocessing

  • Proficiency with the Microsoft Office Suite is required.

  • Proven knowledge and ability regarding product verification and process validations.

  • Good interpersonal, organizational and oral and written communication skills.

  • Comfortable to work with cross functional teams, self-motivated and flexible.

  • Excellent organizational skills.

  • English Fluent, German advantageous but not required.