Validation Engineer Ii
hace 3 semanas
**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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Test Equipment and Method Validation Engineer
hace 6 días
Del Norte, México Covantec A tiempo completo**About Convatec** **About the role** As our new Validation Engineer (1 year contract), you will be responsible for validation and qualification of processes and equipment. You will collaborate closely with cross-functional project teams, and key stakeholders like QA, Regulatory Affairs, R&D, suppliers, and the production units. **Key responsabilities** -...
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Test Equipment and Method Validation Engineer
hace 3 semanas
Del Norte, México Covantec A tiempo completo**About Convatec****About the role**Ensure systems for Software, test method and process equipment validation are following current regulations and procedures already in place.**Key responsabilities**- Establish/maintain necessary local procedures, instructions, and forms for validation test equipment in compliance with current BUID procedures for process...
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Process Engineer Ii 2nd Shift
hace 2 días
Norte, México Johnson & Johnson A tiempo completo**Job Function**:Supply Chain Engineering**Job Sub**Function**:Process Engineering**Job Category**:Scientific/Technology**All Job Posting Locations**:MX301 - Circuito Interior Norte - BWIFueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments.**We are...
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Quality Assurance Engineer
hace 2 semanas
Del Norte, México Convatec A tiempo completo**About the role** The Quality Assurance Engineer will have a key position to support production as main leader, assuring the compliance for regulations, standards, QMS internal procedures on new projects, process improvements, validation & re-validations, risk management and customer complaints investigations. In relation to quality issues from...
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Project Senior Engineer, Facilities
hace 2 semanas
Del Norte, México Convatec A tiempo completoThe Senior Project Engineer is responsible for leading the planning, coordination, and execution of a cleanroom upgrade project. This includes managing cross-functional activities (production, work statement, transportation, installations, testing and commissioning of new infrastructure, facilities, equipment, technical scopes, contractor performance, and...
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Well Engineer, Assoc Ii
hace 2 semanas
Ciudad del Carmen, México Halliburton A tiempo completoWe are looking for the right people — people who want to innovate, achieve, grow and lead. We attract and retain the best talent by investing in our employees and empowering them to develop themselves and their careers. Experience the challenges, rewards and opportunity of working for one of the world’s largest providers of products and services to the...
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Specialist Ii
hace 2 semanas
Del Norte, México Covantec A tiempo completo**About Convatec**Purpose of the function/ position and functional area:**Purpose of the function/ position and functional area**:The purpose of this position is to assure that the implementation of the Label Change are being done in a timely manner, safe and effective.**Responsibilities**:Label Change Coordinator:- The label Change Coordinator is the...
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Continuous Improvement Engineer Ii
hace 2 semanas
Del Norte, México Convatec A tiempo completoWe are guided by our five core values, that shape the way we work, every day: Improve Care, Deliver Results, Grow Together, Own It and Do What’s Right. **Position Overview**: Leading the deployment of standard work & capacity analysis con the plant. This position will solve complex operations problems that drive capacity improvement, space and line...
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Product Quality Engineer
hace 7 horas
Del Norte, México Covantec A tiempo completo**About Convatec****About the role**Participate in changes within the project portfolio in SEG MX ensuring compliance with internal and external requirements according to standards, customer, and authorities; ensuring quality system is developed, maintained, and improved; assuring Process Validation and CCR system is followed accordingly and supporting as...
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Engineer Ii
hace 1 semana
Playa del Carmen, México Marriott International, Inc A tiempo completo**Additional Information** **Job Number**25161058 **Job Category**Engineering & Facilities **Location**The St. Regis Kanai Resort Riviera Maya, Paseo Kanai 15, Solidaridad, Playa Del Carmen, Quintana Roo, Mexico, 77730 **Schedule**Full Time **Located Remotely?**N **Position Type** Non-Management *** Respond and attend to guest repair requests. Communicate...