Validation Engineer Ii

hace 2 días

Del Norte, México Covantec A tiempo completo

**About Convatec****Position Overview**:The Validation Engineer will participate in the process development of projects related with capacity upgrade of existing products and processes, R/D for new products, update of existing products and Revalidation Process Manufacturing.**Key Responsibilities**:**Technical project documentation and activities**:- Participate in Change Control Process (CCRs) for new projects involving theProject Engineering Department.- Develop, establish, maintain, modify, and handle the technical projectdocumentation according to BUIC DK/ UMID MX process development procedure- Participate in gathering the necessary documentation for closure of CCRs- Create, develop and conduct process validation activities.- Coordinate production runs, test runs and any other related activities to processvalidations.- Initial validation of new process equipment, if required based on risk assessment.- Re-validation method and frequency as defined (VMP).- Regular follow up on re-validation plans and that re-validation is performed (VMP).- Assure proper review / approval of validation documentation.Quality documentation and activities:- Participate in writing Process FMECA (P-FMECA)- Responsible for documentation- and performing Factory Acceptance Test (FAT) and Site Acceptance Test (SAT) in cooperation with the BUIC DK/ UMID MX project team and other relevant SMEs e.g., other involved project managers and production sites.- Create validation documentation for New processes, tools, machines, and materials according to local procedures.- Transferred projects.- Re-validation according to instructions and forms for process validation, relevant P-FMECAs and other relevant documents.- Perform validation based on above documents in cooperation with the BUIC DK and/or UMID MX project team and, if relevant, other involved parties e.g., project managers and other production sites.- Perform necessary training of employees participating in validation activities.**About you**:**Skills and Experience**:- About 3 years of experience in similar position.- Experience with performing risk analysis.- Experience with validation of process equipment.- Knowledge of the basic requirements of the FDA QSR, GMP, GAMP, ISO13485 and ISO11607-2.- Basic knowledge in Minitab.- Advanced knowledge of Excel (pivot tables, graphs, formulas, macros etc.)**Qualifications/Education**:- Bachelor's Degree in Industrial Engineering, Mechatronics, Electronics, Mechanical Engineering, or a related field.**What you’ll get**:- Competitive salary + bonus- Training & development- Collaborative, supportive culture**Ready to join us?****Qualifications & Education**:Professional Degree required.LI-SR1LI-Onsite**Beware of scams online or from individuals claiming to represent Convatec****Equal opportunities**Convatec provides equal employment opportunities for all current employees and applicants for employment. This policy means that no one will be discriminated against because of race, religion, creed, color, national origin, nationality, citizenship, ancestry, sex, age, marital status, physical or mental disability, affectional or sexual orientation, gender identity, military or veteran status, genetic predisposing characteristics or any other basis prohibited by law.**Notice to Agency and Search Firm Representatives****Already a Convatec employee?

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