Test Equipment and Method Validation Engineer
hace 3 semanas
**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**- Validation and Qualification of processes and equipment.- Contribute to requirement specification, purchase and implementation of equipment.- Establish/maintain necessary local procedures, instructions, and forms for validation test equipment in compliance with current BUID procedures for process validation and relevant quality standards, incl. GHTF (Global Harmonization Task Force) guidelines for process validation.- Establish/maintain VMP (Validation Master Plan) for re-validation of test equipment & method, including validation history and ensure it is approved by and communicated to relevant areas.- In cooperation with the Maintenance, Production and Eng. Department ensure resource planning for revalidation activities.- Ensure high level of expertise and quality to the equipment and documentation.- Contribute to knowledge sharing across project teams and departments. Ensure necessary training of employees in test equipment and method validation.**Requirements**:- Bachelor’s degree in Industrial Engineering, Process Engineering or related.- Approximately 2 years of experience working with validation process, calibrations and risk assessment.- Basic knowledge and experience of statistic techniques is required.- Experience in cleanroom preffered.- English proficiency: Intermediate - Advanced required- Microsoft profiency: Intermediate - Advanced.Our ambitions will bring the very best out in you. You’ll be pushed to aim higher and really own your work. You’ll be encouraged and supported to make things happen, too. It can be challenging. But, as the progress you make will help improve the lives of millions, it’ll be worth it.This is stepping up to a challenge.This is work that’ll **move** you.LI-AA1LI-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?
-
Test Equipment and Method Validation Engineer
hace 2 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...
-
Validation Engineer
hace 2 semanas
Del Norte, México Covantec A tiempo completo**About Convatec****About the role**As our new Validation Engineer, 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**- Validation and...
-
Validation Engineer
hace 2 semanas
Del Norte, México Convatec A tiempo completo**About Convatec** **About the role** As our new Validation Engineer, 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** - Validation and...
-
Project Engineer Ii
hace 21 horas
Del Norte, México Covantec A tiempo completo**About Convatec** **Position Overview**: Optimize production processes for the use of resources: materials, technology, human talent, always complying with the regulations that govern us. **Key Responsibilities**: **Project Engineer in Production Transfer / Product changes.** - Development of validation documents. - Analysis of results. - Preparation of...
-
Quality Engineer
hace 7 días
Del Norte, México Convatec A tiempo completo**About Convatec****About the role**:Participate in changes within the project portfolio in Convatec 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...
-
Quality Assurance Engineer
hace 2 semanas
Del Norte, México Covantec A tiempo completo**About Convatec** **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...
-
Quality Assurance Engineer
hace 2 semanas
Del Norte, México Covantec A tiempo completo**About Convatec****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...
-
Quality Assurance Engineer
hace 2 días
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 nonconforming...
-
Hardware Security Test Engineer
hace 7 días
Estrella del Pacífico, México NAPS Mexico A tiempo completo**Join NAPS as a Hardware Security Engineer**We’re seeking a highly motivated **Hardware Security Engineer** to join our team and lead efforts on cutting-edge chip technology. If you’re skilled at working under pressure, have experience in system-level and functional testing (block and chip levels), and excel at leading teams, this opportunity is for...
-
Ecsv Senior Analyst
hace 2 semanas
Del Norte, México Covantec A tiempo completo**Key Responsibilities**:The Senior eCSV Analyst will oversee GxP impacting projects to ensure that all applicable regulatory and compliance requirements are met for any new or revised computerized systems to ensure that these systems are not only defendable during an inspection, but also confirm that the delivered systems/services are fit for purpose by...