Consider joining Eurofins Lancaster Laboratories where people are the most important element in our chemistry. Celebrating 50 years of service, Eurofins is a leading contract lab providing testing and research services in the environmental, pharmaceutical, and biopharmaceutical sciences to clients worldwide.
Eurofins Lancaster Laboratories, a nationally recognized laboratory, is searching for a Microbiologist Sterility Assurance Scientist to support our Professional Scientific Services group in Irvine, CA.
- Develop project plans, conduct studies to qualify critical systems, establish sterilization levels and system validation for sterility, antimicrobial and environmental controls including evaluating and updating microbial protocols
- Compose protocols for sterilization or system validation/ sterility and antimicrobial controls; monitor and recommend controls for manufacturing environments, systems, and sterilization processes
- Performs sterility testing utilizing Bac-T Alert
- Identify complex testing approaches to perform microbiological testing, investigations, isolation and identification using FDA and USP guidelines
- Develop complex protocols, reports, and methods in collaboration with inter-departmental teams
- Collect birth tissue samples for studies concerning optimal lot size for sterility sampling
- Lead lab and manufacturing corrective and preventative actions (CAPA) testing
- Train, coach, and guide lower level employees on new procedures, assess work techniques and provide feedback on procedures
- Set parameters of complex laboratory machines applying microbiology knowledge and concepts to perform receiving inspection, raw materials, environmental control testing, in-process solutions, and final product release testing
- Lead process improvement projects and propose recommendations for manager approval
- Interpret data, perform trend analysis, and define qualification strategies for new or modified devices and/or processes
- Make recommendations and validate new laboratory equipment
- Performs other related duties as assigned or requested
- Generate final reports for sterility of GMP products
- Knowledge of cGMP
- Excellent communication (oral and written) and attention to detail
- Excellent oral and written communication skills as well as strong computer
- Must be organized, self-motivated, and capable of working independently or in a collaborative environment
- Bachelor's degree or Master's degree in Microbiology, Biology, or other related biotechnology field
- 1 - 2 years of industry or academic research experience
- Authorization to work in the United States indefinitely without restriction or sponsorship
- Excellent full time benefits including comprehensive medical coverage, dental, and vision options
- Life and disability insurance
- 401(k) with company match
- Paid vacation and holidays
Eurofins Lancaster Laboratories Professional Scientific Services ® (PSS) is a global, award-winning insourcing solution that places our people at our clients' site dedicated to running and managing laboratory services while eliminating headcount, co-employment and project-management worries.
We infuse our 55-year track record of scientific and laboratory operations expertise, as well as HR and great place to work best practices, to recruit, hire, train and manage highly qualified scientists to perform laboratory services using our client's quality systems and equipment.
Eurofins is a M/F, Disabled, and Veteran Equal Employment Opportunity and Affirmative Action employer.