Job Description
We seek a Sr R&D Microbiologist who thrives in a fast-paced environment and is relentless about ensuring project completion and compliance with regulations and expectations. This role focuses on microbial compliance of our products according to relevant regulatory requirements and standards for medical devices. Responsibilities include overseeing and ensuring sustained levels of compliance through testing, monitoring, and validation of cleaning and sterilization processes and associated utilities. You will also lead root cause analysis, technical documentation, and cross-functional collaboration to develop best practices.
MUST HAVE
- Review of validation files for compliance
- Performing sterility release review
- Performing validations and re-qualifications
- Bachelor’s degree in Microbiology or a related discipline
- 6 years’ experience as a Microbiologist in a regulated industry
- Competency in troubleshooting, correction of NC and root cause analysis
- Leads NC and CAPA generation and resolution
- Applying cGLP to all laboratory activities
- Subject matter expertise in internal & external regulatory requirements
- Ensuring compliance of new products to sterile and non-sterile standards
- Providing Technical Assessment for Risk Assessment
- Mentoring and training team members
Work Site
This is a fully on-site position in Cary, Illinois.
Work Environment
Brand new R&D lab. Will work with the team until the team is fully built. Reports to the department head. 1st shift M-F (hours vary).
