Technol, Laboratory - Edwards Lifesciences
Irvine, CA
About the Job
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.
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.
Provide testing services in a laboratory environment.
How You'll Make an Impact:
+ Perform routine and non-routine testing services by using established procedures/protocols (e.g manufacturing investigations, D-value, B&F, FETS, glut, TLS, antimicrobial, sterility, receive, inspect, in process solutions, etc)
+ Review, follow and perform job functions in compliance with established work instructions and adherence with SOPs, including recording traceable information on device history records
+ Perform investigations on CAPA forms e.g., NCRs, RICA, OOT, OOS, for tests or processes nonconformance and identify root cause and propose corrective actions for manager approval
+ Prepare data summaries, reports, and protocols using existing templates as a model as well as review and approve basic laboratory data and may propose recommendation on template changes
+ Assist with routine manufacturing equipment validation by coordinating testing schedules and performing data analysis
+ Create and develop validation plans for laboratory equipment and methods
+ Lead laboratory investigations and propose recommendations and solutions for manager approval
+ Propose and update operating procedures and ensure that specifications are in compliance with GMP, Environment and Safety regulations
+ May train, coach, and guide lower level technicians on new procedures, assess work techniques and provide feedback on procedures
+ Other incidental duties
What You'll Need (Required):
+ Bachelor's Degree in in Chemistry and /or Microbiology Required or
+ Associate's Degree or equivalent 5 years years experience of previous experience working in a laboratory environment Required
What Else We Look For (Preferred):
+ Excellent written and verbal communication, interpersonal, and relationship building skills
+ Able to read, comprehend, write and speak English
+ Excellent computer skills, including usage of MS Office; Analytical Equipment System (e.g ChemStation, Empower) preferred
+ Full knowledge of laboratory processes
+ Full knowledge in QSR (Quality System Regulation), FDA (Food and Drug Administration), and ISO (International Organization for Standardization) regulations
+ Full knowledge in mathematics, e.g., decimals and percentages
+ Ability to write technical documents
+ Strong knowledge with ISO microbiological sterilization documents if applicable
+ 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 an inter-departmental team environment, as well as with colleagues from other departments
+ Ability to provide feedback in a professional, direct, and tactful manner
+ Ability to represent the organization to outside contacts, i.e., vendors
+ 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
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.
For California, the base pay range for this position is $58,000 to $82,000 (highly experienced).
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 protecting our vulnerable patients and the healthcare providers who are treating them. As such, all patient-facing and in-hospital positions require COVID-19 vaccination. If hired into a covered role, as a condition of employment, you will be required to submit proof that you have been 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 locations where it is prohibited by law to impose vaccination.
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.
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.
Provide testing services in a laboratory environment.
How You'll Make an Impact:
+ Perform routine and non-routine testing services by using established procedures/protocols (e.g manufacturing investigations, D-value, B&F, FETS, glut, TLS, antimicrobial, sterility, receive, inspect, in process solutions, etc)
+ Review, follow and perform job functions in compliance with established work instructions and adherence with SOPs, including recording traceable information on device history records
+ Perform investigations on CAPA forms e.g., NCRs, RICA, OOT, OOS, for tests or processes nonconformance and identify root cause and propose corrective actions for manager approval
+ Prepare data summaries, reports, and protocols using existing templates as a model as well as review and approve basic laboratory data and may propose recommendation on template changes
+ Assist with routine manufacturing equipment validation by coordinating testing schedules and performing data analysis
+ Create and develop validation plans for laboratory equipment and methods
+ Lead laboratory investigations and propose recommendations and solutions for manager approval
+ Propose and update operating procedures and ensure that specifications are in compliance with GMP, Environment and Safety regulations
+ May train, coach, and guide lower level technicians on new procedures, assess work techniques and provide feedback on procedures
+ Other incidental duties
What You'll Need (Required):
+ Bachelor's Degree in in Chemistry and /or Microbiology Required or
+ Associate's Degree or equivalent 5 years years experience of previous experience working in a laboratory environment Required
What Else We Look For (Preferred):
+ Excellent written and verbal communication, interpersonal, and relationship building skills
+ Able to read, comprehend, write and speak English
+ Excellent computer skills, including usage of MS Office; Analytical Equipment System (e.g ChemStation, Empower) preferred
+ Full knowledge of laboratory processes
+ Full knowledge in QSR (Quality System Regulation), FDA (Food and Drug Administration), and ISO (International Organization for Standardization) regulations
+ Full knowledge in mathematics, e.g., decimals and percentages
+ Ability to write technical documents
+ Strong knowledge with ISO microbiological sterilization documents if applicable
+ 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 an inter-departmental team environment, as well as with colleagues from other departments
+ Ability to provide feedback in a professional, direct, and tactful manner
+ Ability to represent the organization to outside contacts, i.e., vendors
+ 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
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.
For California, the base pay range for this position is $58,000 to $82,000 (highly experienced).
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 protecting our vulnerable patients and the healthcare providers who are treating them. As such, all patient-facing and in-hospital positions require COVID-19 vaccination. If hired into a covered role, as a condition of employment, you will be required to submit proof that you have been 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 locations where it is prohibited by law to impose vaccination.
Source : Edwards Lifesciences
