Senior Microbiologist required for a medical device multinational in Limerick. The Senior Microbiologist will be responsible for overseeing and conducting quality microbial monitoring program for medical device manufacturing and sterilization. You will also be responsible for setting up and validating the Micro Lab.
Your Responsibilities: (full job spec provided on request)
- Be the on-site technical expert for sterilization validations, controlled environments, routine microbial monitoring requirements, product release testing, providing direction for manufacturing for modifications to controlled environments and facility auxiliaries, and determine requirements for environmental testing.
- Leads special projects as assigned to completion with minimal supervision, developing technically sound protocols and reports and participating in execution of validations/revalidation work.
- Perform critical records documentation and review and participate in documentation preparation and assistance for regulatory audit review.
- Owns internal lab procedures and performs regular reviews of current procedures and processes for improvements and updates as necessary to ensure continued compliance with standards.
- Will train, coach, and guide junior employees on new and ongoing processes and procedures assess work techniques, and provide feedback.
- Bachelor’s degree in Microbiology.
- Minimum 6 years previous experience in a microbiology environment which includes knowledge of FDA & EU testing requirements, standards, applicable lab techniques, test method validations, and quality assurance evaluations.
- Knowledge of and experience with microbiology laboratory testing for medical device company is required.
- Direct experience with sterilization validations and testing of medical devices, not limited to aseptic techniques for bioburden and sterility tests, culture maintenance, organism identification and characterization, manufacturing processes, systems, and facilities, qualification involving sterilization processes, and environmental controls.
- Previous experience in supervising direct reports or teams required.
What you will get in return:
- Education Allowance.
For a confidential discussion and more information on the role, please contact Aisling Lane.