Job Title: Senior Microbiology Process Specialist
About the Role
We are seeking an experienced microbiologist to take ownership of microbiological quality processes at our plant. In this role, you will ensure that all products manufactured meet both microbiological and sterilization standards.
You will work closely with regulatory guidelines and lead a team of microbiology technicians to maintain these standards across the site. Additionally, you will oversee compliance with sterilization protocols and radiological protection.
Key Responsibilities
* Ensure that all products manufactured comply with global microbiological and sterilization requirements.
* Maintain a comprehensive understanding of relevant regulatory requirements for microbiology and sterilization.
* Supervise and support a team of microbiology technicians, ensuring consistent application of microbiological quality standards.
* Oversee sterilization and environmental monitoring requirements, ensuring compliance with regulatory guidelines.
* Lead dose establishment, dose audits, and dose mapping, preparing cycle time charts as needed.
* Conduct thorough reviews of processed product lots, ensuring they meet quality standards before approving them for release.
* Act as the microbiological technical expert, troubleshooting and solving complex microbiological issues.
Experience and Education Requirements
To be successful in this role, you should have:
* A degree in Science or a related Quality discipline with a specialization in Microbiology.
* At least 3-5 years' experience in a similar role, ideally within the healthcare industry.
* Experience with radiation and sterilization processes is an advantage.
* Familiarity with process validation and cleanroom environments is an advantage.
* Strong leadership, interpersonal, and communication skills.
* High level of computer literacy, with proficiency in Microsoft Office applications.