We are currently seeking a Microbiologist for one of our clients in Le Locle, Canton of Neuchatel.
If you are looking to work in a dynamic and very friendly working environment in the medical devices sector, then this is for you.
This is an open-ended temporary contract via Randstad.
Please note this vacancy requires fluency in French and English.
Start: ASAP (max 1 month of notice period)
Your responsibilities:
* Ensures that adequate Microbiology support is provided to productions and to open projects / initiatives.
* Ensures that Non Conformances 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.
* 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.
* Review and approve laboratory documents & sterilization certificates.
* Review and assess supplier changes from clean/sterilization aspect.
* Lead or coordinate sterility assurance projects.
* Interact with manufacturing, quality teams, contract sterilizers & laboratories.
* Ensures that GMP rules are known, understood and respected on the site.
* Ensure technical support to laboratory department.
* Participates and supports internal and third party audits / inspections.
* Provides support to complaint investigation if required.
* Participate to procedure elaboration or update.
* 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.
Your profile:
* A minimum of a Bachelor Science Degree is required.
* Minimum 1 year experience as a Microbiologist in a medical device, pharmaceutical, or similar regulated industry.
* Fluent in French and English.
* Knowledge of Medical device standards and regulations such as ISO13485, 93/42 EEC, 21 CFR part 820.
* Good communication, organizational, negotiation and interpersonal skills.
* Strong teamwork and communication skills to work effectively on cross-functional project teams.
* Good analytical problem solving skills.
* Use of Agile, Oracle, EtQ, Minitab.
* Use of Microsoft office tools.
* Good knowledge of statistical techniques.
We are looking forward to receiving your application.
Please note that if you are NOT a passport holder of the country for the vacancy, you might need a work permit.
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