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Microbiologist

vor 3 Monaten

Le Locle, Neuenburg, Schweiz Integra LifeSciences Vollzeit
Changing lives. Building Careers.


Joining us is a chance for you to do important work that creates change and shapes the future of healthcare.

Thinking differently is what we do best. To us, change equals opportunity. Every day, more than 4,000 of us are challenging what's possible and making headway to help improve outcomes.

Responsabilities

  • Ensures that adequate Microbiology support is provided to productions and to open projects / initiatives
  • Ensures that Nonconformances related to sterilization, contamination & OOS laboratory are initiated, dispositioned, approved and investigated according to plans and in compliance with procedures and regulatory requirements
  • Develop, validate and/or requalify cleaning, gamma/ethylene oxide and/or steam sterilization processes for existing, modified product and new products o Validate & Manage routine environmental monitoring (clean room, water/air/gas systems, analyze and report results).
  • Manage site bioburden and dose audit programs
  • Carry out microbiology/HPLC laboratory investigation o Review and approve laboratory documents & sterilization certificates.
  • Support equipment qualification affecting cleanliness/sterilization o Review and assess supplier changes from clean/sterilization aspect
  • Lead or coordinate sterility assurance projects o lnteract with manufacturing, quality teams, contract sterilizers & laboratories
  • Ensures that GMP rules are known, understood and respected on the site o Ensure technical support to laboratory department
  • Participates and supports internal and third party audits / inspections o Provides support to complaint investigation if required
  • Participate to procedure elaboration or update o Ensures that CAPA related to sterilization, contamination & OOS laboratory are managed and documented according to plans and in compliance with procedures
  • Ensure resources are correctly filled in the project database
Qualification

  • Bachelor of Science Degree
  • Minimum 25 years experiences as a Microbiologist in a medical device, pharmaceutical, or similar regulated industry
  • Proven knowledge of FDA and MDD GMP requirements regarding medical Devices
  • French speaker and Fluent in English
  • Good interpersonal, organizational, oral and written communication skills.
  • Strong teamwork and communication skills to work effectively on crossfunctional project teams
  • Problemsolving and continuous improvement oriented