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.

Ensures that adequate Microbiology support is provided to productions and to open projects / initiativesEnsures that Nonconformances related to sterilization, contamination & OOS laboratory are initiated, dispositioned, approved and investigated according to plans and in compliance with procedures and regulatory requirementsDevelop, validate and/or requalify cleaning, gamma/ethylene oxide and/or steam sterilization processes for existing, modified product and new productsValidate & Manage routine environmental monitoring (clean room, water/air/gas systems, analyze and report results)Manage site bioburden and dose audit programsCarry out microbiology/HPLC laboratory investigationReview and approve laboratory documents & sterilization certificatesSupport equipment qualification affecting cleanliness/sterilizationReview and assess supplier changes from clean/sterilization aspectLead or coordinate sterility assurance projectsInteract with manufacturing, quality teams, contract sterilizers & laboratoriesEnsures that GMP rules are known, understood and respected on the siteEnsure technical support to laboratory departmentParticipates and supports internal and third party audits / inspectionsProvides support to complaint investigation if requiredParticipate to procedure elaboration or updateEnsures that CAPA related to sterilization, contamination & OOS laboratory are managed and documented according to plans and in compliance with proceduresEnsure resources are correctly filled in the project database

Qualifications:

A minimum of a Bachelor Science Degree is requiredMinimum 5 year experiences as a Microbiologist in a medical device, pharmaceutical, or similar regulated industryFluent in French and EnglishKnowledge of Medical device standards and regulations  such as ISO13485, 93/42 EEC, 21 CFR part 820Good communication, organizational, negotiation and interpersonal skillsStrong teamwork and communication skills to work effectively on cross-functional project teamsGood analytical problem solving skillsUse of Agile, Oracle, EtQ, MinitabUse of Microsoft office toolsGood knowledge of statistical techniques