Senior Microbiologist
Vor 3 Tagen
At Integra LifeSciences, we are seeking a highly skilled Senior Microbiologist to join our team in Le Locle. As a key member of our quality team, you will be responsible for ensuring the highest standards of microbiological quality in our manufacturing processes.
Key Responsibilities:
- Develop and execute microbial method validation protocols and reports.
- Design experimental plans for microbiological quality issues.
- Oversee sample processing and ensure timely testing and reporting.
- Ensure compliance with microbiology procedures and regulations (e.g., FDA, ISO).
- Analyze microbiological data to identify trends and issues.
- Contribute to risk management and PFMEA activities.
- Coordinate scheduling, material allocation, and personnel for project completion.
- Create site procedures for microbiological testing and sampling.
- Mentor junior microbiology staff.
- Represent Microbiology in cross-functional teams and supervise contract resources.
- Support sterilization and microbiological test method validations.
- Participate in FDA inspections, ISO certifications, and audits.
Requirements:
- Bachelor's degree in Microbiology or related field (Master's or Doctoral preferred). 6+ years of experience with a Bachelor's, 3+ years with a Master's, or 2+ years with a Doctoral degree.
- Expertise in one controlled environment monitoring, water system monitoring, endotoxin testing, bioburden testing, sterilization validation, and reprocessible device cleaning.
- Excellent organizational, communication, and technical writing skills.
- Proven ability to manage projects and create procedural documentation.
- Knowledge of microbiology standards and applicable regulations.
- Ability to travel 50% or more.
Desired Skills:
- Experience with microbial test method validations and project management.
- Proficiency in microbiological monitoring standards and regulations.
Job ID:
JR-2356
Job Area:
Engineering and ScienceFunction: Laboratory/Hematology/Chemistry/MicrobiologyIndustry: Healthcare/Medical
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