Edwards Lifesciences Staff Microbiologist in Cartago, Costa Rica
Address complex compliance and risk assessment activities related to new product development and manufacturing sustaining activities as it relates to contamination control and sterility assurance.
• Qualify complex laboratory instrumentation and validate complex test methods while applying microbial knowledge and concepts to perform environmental control testing, in-process solutions, and final product release testing for device qualifications
• Lead in the development of complex technical protocols, reports, and methods in collaboration with intra and inter-departmental teams
• Provide strategy and guide other microbiologists on root cause analysis for product/sample failures, Out-of-Specifications (OOS), non-conformances investigations
• Train, coach, and guide lower level employees on complex equipment and test methods, assess work techniques and provide feedback on policies and procedures
• Lead laboratory manufacturing sustaining operations activities including maintaining work schedules to align with production
• Provide solutions and lead in the validation of new laboratory equipment
• Lead complex critical system improvement projects (e.g. BEST, Lean) and work with team to provide solutions
• May be a on a working group/committee in support of a compliance guide. May need to serve as legal technical representative (regent) subscribed to the correspondent professional board (Colegio de Microbiólogos y Químicos Clínicos de Costa Rica) to oversee safe and adequate laboratory processing, and to oversee assigned professional and technical duties
• Other incidental duties:
Education and Experience:
Bachelor's Degree in in Microbiology , 8 years experience of previous related experience Required
• Proven successful project management skills
• Proven expertise in MS Office
• Excellent facilitation and presentation skills
• Excellent problem-solving, organizational, analytical and critical thinking skills
• Adhere to all EHS 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
• Extensive knowledge and understanding of Edwards’ policies and procedures relevant to microbiology which includes contamination control and sterilization.
• Thorough knowledge of the compliance guides for environmental controls or a sterilization process
• Extensive knowledge and understanding of Microbiology principles, theories and concepts.
• Extensive knowledge of laboratory equipment.
• Full knowledge in the review, evaluation, interpretation, and implementation of internal and external guidance's (e.g., ISO, GLP/GMP/QSIT)
• Advanced proficiency in Microsoft Office Suite, including Word, Excel, and PowerPoint
• Excellent written and verbal communications skills
• Advanced problem-solving skills
• Ability to manage confidential information with discretion
• Strong leadership skills and ability to influence change
• 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
• Ability to work in a team environment, including frequent inter-organizational and outside customer contacts
• Ability to represent the organization in providing solutions to difficult technical issues associated with specific projects
Edwards Lifesciences is the global leader in patient-focused medical innovations for structural heart disease, as well as critical care and surgical monitoring. Driven by a passion to help patients, the company collaborates with the world's leading clinicians and researchers to address unmet healthcare needs, working to improve patient outcomes and enhance lives. Headquartered in Irvine, California, Edwards Lifesciences has extensive operations in North America, Europe, Japan, Latin America and Asia and currently employs over 15,000 individuals worldwide.
For us, helping patients is not a slogan - it's our life's work. From developing devices that replace or repair a diseased heart valve to creating new technologies that monitor vital signs in the critical care setting, we focus on helping patients regain and improve the quality of their life.