Microbiology Supervisor

Job content

Integra LifeSciences is a global leader in regenerative technologies and neurosurgical solutions dedicated to limiting uncertainty for clinicians, so they can focus on providing the best patient care.

Founded in 1989, Integra develops, manufactures, sells and supplies best-in-class products to regenerate tissue, remove brain tumors, prevent infection and much more. And over the last three decades, we’ve evolved into one of the world’s leading global medical technology companies with more than 4,000 dedicated employees who deliver innovative medical technology solutions.

But that’s just the beginning. Integra is growing at an unprecedented rate. We’re at a moment in time where the experience you’ll gain is more robust than the experience you bring. And we’re out to invest in your future because it’s the best way to maximize ours.

Responsibilities

• Management of the microbiologists and the laboratory technicians: Organize necessary resources to support activities. Ensure that goals and objectives are set and followed for every team member in accordance with companies G&O’s. Make sure that resources are adequately documented in the project database
• Ensures that adequate Microbiology support is provided to productions and to open projects / initiatives
• Ensures that Nonconformances related to sterilization, contaminations and OOS laboratory are initiated, dispositioned, approved and investigated according to plans and in compliance with procedures and regulatory requirements
• Ensures validation and management of Environmental monitoring (clean room, water, air, gas)
• Ensures validation /revalidation of all sterilization processes (ETO, Gamma and steam), including for new products
• Ensures management of bioburen and dose audit programs
• Review and approve laboratory documents and sterilization certificates
• Ensure technical support to the laboratory
• Review and assess supplier changes from a clean / sterilization aspect
• Ensures that Sterility and laboratory indicators are established and communicated
• Participates and supports internal and third-party audits / inspections
• Manages or participates to quality projects
• Provides support to complaint investigation if required
• Participates to procedure elaboration or update
• Ensures that CAPA under microbiology department responsibilities are managed and documented according to plans and in compliance with procedures
• Ensures support to process improvement projects
• Ensures that equipments in the laboratory are functional and correctly used in collaboration with maintenance and calibration

Authorities:

• People management (including evaluation)
• Product acceptation / rejection
• Release of sterilization (ETO, Steam, Gamma)
• NC and CAPA Approval / Rejection
• Change Order Approval / Rejection
• Validation approval/ rejection

Qualifications

• A minimum of a Bachelors Degree is required in Life Science discipline.
• Minimum 5 years of professional work experience as microbiologist
• Experience working in a Medical Device / pharmaceutical manufacturing.
• Fluent in French and English
• Knowledge of Medical device standards and regulations such as ISO13485, 93/42 EEC, EUMDR, 21 CFR part 820
• Strong management & Leadership skills
• Strong communication, organizational, negotiation and interpersonal skills
• Strong analytical problem-solving skills.
• The ability to collaborate with all levels of management across multiple sites and functions
• Use of Microsoft office tools
• Strong knowledge of statistical techniques