Microbiologist I (Onsite)

About the role

When you join the team at Cordis, you become part of an inspiring mission to save lives, impacting millions of people and broadening access to life-saving cardiovascular and endovascular technology. As a global leader for over 60 years, we are dedicated to being the heart of innovation to transform cardiovascular care. At Cordis, we're teammates, not just employees. We embrace an empowered and one-team culture where teammates are inspired to unleash their full potential. With diverse teams on a global scale, we believe the richness of our experiences and backgrounds enhances the careers of our teammates, the service to our customers, and ultimately, the lives of our patients. If you love a challenge and are ready to have a direct, transformative and positive impact on the lives of millions, then Cordis is just the place for you. We are the people behind the people who keep saving lives.

Responsibilities

• Perform routine environmental monitoring of cleanrooms and controlled areas, including particles, surface, air and compressed gases.
• Responsible for writing, reviewing, approving sterilization and microbiology technical protocols and reports.
• Works with contract sterilizers on planning, scheduling, reviewing sterilization validations and dose audits.
• Perform laboratory testing as required to include bioburden, bacterial endotoxin testing, water testing and test method validation of microbiology equipment.
• Initiate, participate in, and close laboratory investigations related to nonconforming laboratory test results and/or environmental monitoring processes, product testing, or laboratory equipment failures.
• Provides support with microbiology and sterilization non-conformances, analysis of data and provides recommendations for improvements.
• Will be considered the site technical expert with assistance from experienced subject matter experts in microbiology and sterilization during audits.
• Perform routine calibration and verification and maintenance of laboratory equipment and instruments in accordance with Standard Operating Procedures. (SOPs)
• Work in compliance with current Good Manufacturing Practices (GMPs) regarding documentation, testing, maintenance, laboratory notebooks, and data sheets and ensuring accuracy.
• Collect and prepare laboratory records for evaluation in accordance with good documentation practices and distribute reports as necessary and make changes to procedures as needed.
• Train/certify others in various testing procedures and techniques as required.
• Participate in projects as required.
• Ensure compliance with local, state, and federal regulations, as well as company policies and procedures, and act in accordance with the Safety, Health, and Environmental (EHS) department requirements.
• Perform other laboratory-related tasks as assigned by management.
• Support internal laboratory, environmental, and safety management activities.
• Follow procedures and policies related to EHS that are established at the site and participate in safety and environmental programs.
• Report hazards and incidents and collaborate in identifying solutions or implementing improvements.
• Prepare and present laboratory metrics.
• Responsible for purchasing and designing equipment that meets safety and environmental requirements.
• Support product development, validations, microbiological evaluations of consumables, manufacturing-area changes, method transfers, and all testing activities.
• Review and approve sterilization process records as required and ensure the timely and appropriate release of sterile loads.
• Perform other assigned tasks as necessary.

Qualifications

Required Qualifications:

• Requires a Bachelor's degree with no previous professional experience.
• Where required, the role must hold an appropriate degree in the industry (e.g., Legal).

Preferred Qualifications:

• Must be proficient in Microsoft Word, Microsoft Project, Excel, and PowerPoint and Visio.
• Experienced with developing spreadsheet models, presentations.
• Ability to effectively solve complex problems and ability to communicate across all functional groups and levels is a requirement.
• Must be able to support multiple projects and experience in driving results.
• Must have knowledge of GMP, QSR, ISO Standards, must have experience working with implantable medical devices.
• The position may require a combination of being onsite and remote.