Microbiology Scientist Ii

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 / 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
- 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

Qualifications:

- A minimum of a Bachelor Science Degree is required
- Minimum 5 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