Descripción de la oferta
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 16,000 talented team members and five other production plants. Our new facility in Moncada will welcome up to 1,500 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):
Bachelor's Degree in Chemistry, 4 years experience in chemistry environment, or
Master's 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 guidance's (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
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