Senior Chemist

València - Spain

Monthly Salary: Not Disclosed

Posted on: Yesterday

Vacancies: 1 Vacancy

Job Summary

We recently announced plans to expand in Spain by building a new state-of-the-art manufacturing plant in Moncada Valencia. When it becomes operational in 2026 the plant will manufacture Edwards surgical and transcatheter heart valve replacement technologies and will join a global network of more than 16000 talented team members and five other production plants. Our new facility in Moncada will welcome up to 1500 dedicated team members by 2029 across manufacturing engineering and several other professional career paths. Hiring for professional positions has started and will continue through the winter and early spring with specialized training for manufacturing hires beginning in the fall of 2025.

How You Will Make an Impact:

This position is responsible for validating test methods qualifying equipment testing and releasing of raw and in-process materials in support of manufacturing operations.
Lead the test method development transfer and validation and routine/in-process testing on using gas chromatography high performance liquid chromatography titration osmolality pH and UV/Vis spectroscopy.
Lead Chemistry laboratory operations activities including maintaining work schedules to align with production
Develop execute and maintain the Master Validation Plan for the Quality Chemistry lab.
Qualify complex laboratory instrumentation and validate complex test methods while applying chemistry knowledge and concepts to perform environmental control testing in-process solutions and final product release testing for device qualifications
Provide solutions and lead in the qualification of complex manufacturing processes.
Train coach and guide lower level employees on new procedures assess work techniques and provide feedback on procedures
Provide strategy on root cause analysis for product/sample failures and Out-of-Specifications (OOS) non-conformances and CAPA and guide other chemists perform investigations
Investigate and perform lab and manufacturing corrective and preventative actions (CAPA) testing
Lead complex process improvement projects (e.g. BEST Lean) and work with team to provide solutions
Other incidental duties

What You Will Need (Required):

Bachelors Degree in Chemistry 4 years years experience in chemistry environment or
Masters Degree or equivalent in Chemistry 2 years experience in chemistry environment
Excellent written and verbal communication skills in English

What Else We Look For (Preferred):

Extensive knowledge of laboratory equipment such as HPLC GC UV-Vis TOC FT-IR
Full knowledge in the review evaluation interpretation and implementation of internal and external guidances (e.g. ISO GLP/GMP/QSIT)
Demonstrated problem-solving and critical thinking skills
Advanced proficiency in Microsoft Office Suite including Word Excel and PowerPoint
Advanced problem-solving skills
Strict attention to detail
Knowledge of Good Manufacturing and Good Documentation Practices supporting a medical device environment
Knowledge of and adherence to Environmental Health and Safety and Quality guidelines as they relate to clean room medical device manufacturing
Ability to interact professionally with all organizational levels
Ability to manage competing priorities in a fast paced environment
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

Required Experience:

Senior IC

How You Will Make an Impact:

This position is responsible for validating test methods qualifying equipment testing and releasing of raw and in-process materials in support of manufacturing operations.
Lead the test method development transfer and validation and routine/in-process testing on using gas chromatography high performance liquid chromatography titration osmolality pH and UV/Vis spectroscopy.
Lead Chemistry laboratory operations activities including maintaining work schedules to align with production
Develop execute and maintain the Master Validation Plan for the Quality Chemistry lab.
Qualify complex laboratory instrumentation and validate complex test methods while applying chemistry knowledge and concepts to perform environmental control testing in-process solutions and final product release testing for device qualifications
Provide solutions and lead in the qualification of complex manufacturing processes.
Train coach and guide lower level employees on new procedures assess work techniques and provide feedback on procedures
Provide strategy on root cause analysis for product/sample failures and Out-of-Specifications (OOS) non-conformances and CAPA and guide other chemists perform investigations
Investigate and perform lab and manufacturing corrective and preventative actions (CAPA) testing
Lead complex process improvement projects (e.g. BEST Lean) and work with team to provide solutions
Other incidental duties

What You Will Need (Required):

Bachelors Degree in Chemistry 4 years years experience in chemistry environment or
Masters Degree or equivalent in Chemistry 2 years experience in chemistry environment
Excellent written and verbal communication skills in English

What Else We Look For (Preferred):

Extensive knowledge of laboratory equipment such as HPLC GC UV-Vis TOC FT-IR
Full knowledge in the review evaluation interpretation and implementation of internal and external guidances (e.g. ISO GLP/GMP/QSIT)
Demonstrated problem-solving and critical thinking skills
Advanced proficiency in Microsoft Office Suite including Word Excel and PowerPoint
Advanced problem-solving skills
Strict attention to detail
Knowledge of Good Manufacturing and Good Documentation Practices supporting a medical device environment
Knowledge of and adherence to Environmental Health and Safety and Quality guidelines as they relate to clean room medical device manufacturing
Ability to interact professionally with all organizational levels
Ability to manage competing priorities in a fast paced environment
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

Required Experience:

Senior IC

Key Skills

Business Consulting
Gas Chromatography
Laboratory Experience
Analytical Chemistry
FDA Regulations
Wet chemistry
Chromatography
High-Performance Liquid Chromatography
Spectroscopy
GLP
cGMP
Organic Chemistry

Apply Now

About Company

Edwards Lifesciences

Edwards Lifesciences (NYSE: EW), is the global leader of patient-focused medical innovations for structural heart disease and critical care monitoring. We are driven by a passion for patients, dedicated to improving and enhancing lives through partnerships with clinicians and stakehol ... View more

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