CASY-MSCCN Jobs

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We are looking for a senior-level Microbiologist to serve as a subject matter expert within one or more of the areas listed below:

* Controlled environment monitoring

* Water system monitoring

* Bacterial endotoxin test method validation and monitoring

* Bioburden test method validation and monitoring

* Reusable Medical Devices

* Radiation sterilization validation and dose audit management

* Ethylene oxide sterilization validation and requalification

* Reprocessible device cleaning and sterilization validation

The ideal candidate would have a proven ability to thrive both independently and in a team setting. The role involves researching, investigating, and ensuring compliance with clean room practices, cGMP, and GLP environments. The candidate will support microbiological and sterility assurance activities at our Le Locle manufacturing site and report to the Director of Quality Reliability Microbiology, with a dotted line to the local site quality leader.

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.

Required Qualifications:

• 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 5-10%.

Desired Skills:

• Experience with microbial test method validations and project management.

• Proficiency in microbiological monitoring standards and regulations.