This position will be responsible for overseeing and conducting quality microbial monitoring program for medical device manufacturing and sterilization, and quality assurance reviews. In addition, will perform and oversee microbiological testing for medical devices, manufacturing processes, systems, and facilities.
Key responsibilities to include:
- 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.
- Works closely with other departments to ensure continued compliance to standards that govern manufacturing controlled environments.
- 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. Review and approve environmental monitoring data, escalates issues to management.
- Performs root cause investigations and implement correction/corrective actions for controlled environment related excursions, with minimal supervision.
- Owns internal lab procedures and performs regular reviews of current procedures and processes for improvements and updates as necessary to ensure continued compliance to standards.
- Execute process validations/revalidations, in relation to setting up new laboratory equipment, assisting with protocols, data analysis, temperature studies, and reports, to contribute to goal achievements.
- Responsible for managing various tasks within the lab environment, juggling different priorities, and meet communicated deadlines.
- Utilize communication skills as an important member of audits, and for participation in team / global goals; apply judgment, support development projects, problem-solving leadership, impact evaluation, and apply regulatory compliance standards.
- Will train, coach, and guide lower level employees on new and ongoing processes and procedures, assess work technique and provide feedback. May have the opportunity to lead a small team.
- Bachelor’s degree in with a minimum 6 years previous experience in a microbiology environment or Master’s degree in Microbiology
- 4 years of related experience, which includes knowledge of FDA &EU testing requirements, standards, applicable lab techniques, test method validations, and quality assurance evaluations.
Additional qualifications include:
- Knowledge of and experience with microbiology laboratory testing for medical device company is required. Knowledge of and experience working in a GLP compliant lab is desired.
- Direct experience with sterilization validations and testing of medical devices, not limited to aseptic techniques for bioburden and sterility tests, culture maintenance, organism