- Conduct studies to 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
- Identify more complex testing approaches to perform microbiological testing, investigations, isolation and identification using Edwards and outside guidance standards
- Develop protocols, reports, and methods in collaboration with inter-departmental teams
- Collect samples for studies
- Investigate and perform lab and manufacturing corrective and preventative actions (CAPA) testing
- May 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 smaller process improvement projects (e.g. BEST, Lean) 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
- Other incidental duties assigned by Leadership
- Proven expertise in MS Office Suite
- Excellent written and verbal communication skills and interpersonal relationship skills
- Demonstrated problem-solving and critical thinking skills
- Moderate knowledge and understanding of Edwards policies and procedures relevant to microbiology
- Moderate knowledge and understanding of microbiology principles, theories and concepts
- Moderate understanding of at least one of the following areas: sterilization process, final release testing, and environmental controls
- Advanced proficiency in Microsoft Office Suite, including Word, Excel, and PowerPoint
- Excellent written and verbal communications skills
- Advanced problem-solving skills
- Knowledge of and adherence to Edwards Environmental Health and Safety and Quality guidelines as they relate to department clean room medical device manufacturing
- Strict attention to detail
- Knowledge of Good Manufacturing and Good Documentation Practices supporting a medical device environment
- Ability to interact professionally with all organizational levels
- Ability to manage competing priorities in a fast paced environment
- Work is performed independently on more complex projects and/or lines of work and reviewed for accuracy and soundness
- Adhere to all company rules and requirements (e.g., pandemic protocols, Environmental Health & Safety rules) and take adequate control measures in preventing injuries to themselves and others as well as to the protection of environment and prevention of pollution under their span of influence/control
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Microbiologist II, Quality - Irvine, United States - Edwards Lifesciences Corp
Description
Make a meaningful difference to patients around the world.At Edwards Lifesciences facilities around the world, our Manufacturing teams create the tools, technologies, and devices that transform patients' lives.
As part of our sewing, assembly, delivery, and distribution teams, your attention to detail and commitment to continuous improvement will help us turn innovative ideas into reality.
Your purpose-driven work will help leave lasting and positive impacts on patient lives.Dedicated to innovation, our Surgical business unit is focused on identifying and solving critical, unmet needs in cardiac surgery.
In understanding the challenges of open-heart surgery, we partner with surgical teams to deliver modern technologies intended to enhance patients' quality of life and expand their potential treatment opportunities.
It's our driving force to help patients live longer and healthier lives. Join us and be part of our inspiring journey.How You'll Make an Impact:
What You'll Need (Required):
Bachelor's Degree in Microbiology, 2 Years experience in a microbiology environment Required or
Master's Degree or equivalent in Microbiology experience in a microbiology environment Required and
Experience with aseptic techniques for bioburden and sterility tests, microbiological inoculums, assays, pipettes, identification and characterization, testing of medical devices, manufacturing processes, systems, and facilities, qualification involving sterilization processes, and environmental controls
What Else We Look For (Preferred):
Aligning our overall business objectives with performance, we offer competitive salaries, performance-based incentives, and a wide variety of benefits programs to address the diverse individual needs of our employees and their families.
The pay for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience). Applications will be accepted while this position is posted on our Careers website.
Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.
COVID Vaccination Requirement
Edwards is committed to complying with the requirements and guidance from our government authorities and to protecting our vulnerable patients and the healthcare providers who are treating them around the world.
As such, all Healthcare Interacting positions require COVID-19 vaccination, which includes anyone who directly interfaces with patients and those who interact with healthcare providers as part of their role.
If hired, as a condition of employment, you will be required to submit proof that you have been fully vaccinated for COVID-19, unless you request and are granted a medical or religious accommodation for exemption from the vaccination requirement.
This vaccination requirement does not apply in countries where it is prohibited by law to impose vaccination.In countries where vaccines are less available, or other requirements exist, we may institute alternate measures that optimize patient safety and healthcare provider safety, which may include regular COVID testing or specific masking requirements.
