About this role
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.
Role
Provides technical and function-specific knowledge to support laboratory microbiological and chemistry testing activities.
How You Will Make An Impact?
- Perform routine testing services using established procedures/protocols (e.g sterility, bioburden, aseptic filtration, environmental collection and testing, receive, inspect, in process solutions, etc)
- Collect environmental lab samples from multiple cleanrooms
- Perform data entry of routine testing
- Review, follow and perform job functions in compliance with established work instructions and adherence with SOPs, including recording traceable information on device history records
- Assist in testing validation/revalidation activities for critical systems and equipment under close supervision
- May maintain basic equipment by following procedures and executing PM (preventative maintenance) per established schedule
- Update operating procedures and ensure that specifications are in compliance with GMP, Environment and Safety regulations
- Other incidental duties
What You Will Need?
- Associate's Degree or equivalent in a related science field , 1 year experience working in a laboratory environment Required
- Good written and verbal communication, interpersonal, and relationship building skills
- Able to read, comprehend, write and speak English
- Good computer skills, including usage of MS Office
- Moderate knowledge of laboratory processes
- Moderate knowledge in QSR (Quality System Regulation), FDA (Food and Drug Administration), and ISO (International Organization for Standardization) regulations
- Moderate knowledge in mathematics, e.g., decimals and percentage
- 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
- Must be able to work in a team environment
- Ability to provide feedback in a professional, direct, and tactful manner
- Adhere to all company rules and requirements 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