Microbiologist
We are currently seeking a Microbiologist for one of our clients in Canton of Neuchatel.
If you are looking to work in a dynamic and very friendly working environment and in the medical devices sector then this is for you.
This is an open ended temporary contract.
Please note this vacancy requires fluency in French.
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
Support equipment qualification affecting cleanliness/sterilization
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 experiences 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
Those lines sound interesting ? We are looking forward to receiving your application.
