Microbiologist I (Onsite)

Cordis, LLC; Santa Clara (CA); Vor Ort; USD 85.000 - 110.000; Vollzeit

Zusammenfassung

Cordis, LLC is seeking a Microbiologist I to support sterility assurance, environmental monitoring, and method validations in a GMP environment. You will help write and review microbiology protocols, coordinate with sterilization vendors, and contribute to continuous improvement of laboratory practices.

The role requires a Bachelor’s degree with no professional experience and offers a path to grow as a site technical expert while ensuring compliance with U.S. and international regulations.

Qualifikationen

• Bachelor's degree required with no prior professional experience.
• Experience with GMP documentation and lab notebooks is a plus.

Aufgaben

• Perform routine environmental monitoring of cleanrooms and controlled areas.
• Write, review, and approve sterilization and microbiology protocols and reports.
• Ensure compliance with GMPs and safety requirements; participate in audits and investigations.

Kenntnisse

Microbiology

GMP knowledge

Ausbildung

Bachelor's degree

Jobbeschreibung

Overview

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

The Microbiologist I reports to the Sterility Assurance Organization. This position requires experience in contamination control, cleanroom technology, different sterilization modalities such as Ethylene Oxide, Gamma, and E-Beam. Must have excellent communication, presentation and technical writing skills and be able to write technical protocol and reports, be proficient and knowledgeable with both US and International microbiology and sterilization regulations and standards.

Job Responsibilities

Includes the following. Other duties may be assigned depending on the needs of the business.

• 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 (eg. Legal)