Validation Engineer 2
hace 4 días
Validation Engineer II Responsibilities Completes projects as assigned by the department manager. Must be able to prioritize responsibilities and establish timelines in order to maintain a balance of support in all projects and execute projects with clear objectives. Generates and revises validation protocols SOPs drawings equipment specifications Engineering Test Reports (ETR) and technical reports. Proficiently develops and performs testing and evaluation of process validations and software validations in compliance with all Installation Qualifications (IQ), Operational Qualifications (OQ) and Performance Qualification (PQ). Documents all activities appropriately. Evaluates and executes validation/requalification. Maintains and assists in establishing standardized methods and procedures for software process and test method validations and ensure standardized methods are implemented and followed. Maintain compliance with applicable GMP standards ISO Standards local Standard Operating Procedures (SOP)s and company policies. Maintain a safe work environment for self and other employees. Works on problems of moderate scope where analysis of situation or data requires a review of a variety of factors. Exercises judgment within defined procedures and practices to determine appropriate action. Qualifications Bachelors Degree required preferably in Mechanical, Electrical, Electromechanical or Biomedical Engineering. Minimum 2 - 5 years of related experience; or an advanced degree without experience. Bilingual (English/Spanish). Good working knowledge of production processes SOPs drawings machine specifications and required test equipment/fixtures. Ability to read analyze and interpret common scientific and technical reports technical procedures validation protocols and reports operating instructions and regulations. Ability to write reports business correspondence and procedures. Must be able to prepare clear and informative engineering and technical reports with accuracy. Ability to work with mathematical concepts such as probability statistical inference and fundamentals of plain and solid geometry and trigonometry on a scientific level. Ability to define problems collects data establish facts and draw valid conclusions. Ability to effectively present information to upper management and other groups. Capable of working independently and is self-motivated to improve skill set related to recognized process validation techniques. Effective in written and verbal communications. Good understanding of software management Tools spreadsheets and word processing software. Ability to apply logical and scientific critical thinking to a wide range of intellectual and practical problems. Understanding of relationship between medical device manufacturer and regulatory agencies which monitor them. U.S.A Visa required. Availability to travel to the U.S. and other country if required. Key Skills Python SOC Debugging C/C++ FDA Regulations Minitab Technical Writing GAMP OS Kernels Perl cGMP Manufacturing Employment Type: Full-Time Experience: years Vacancy: 1 Yearly Salary: 2 - 5 #J-18808-Ljbffr
-
Validation Engineer 2
hace 3 días
Reynosa, México Fresenius Medical Care A tiempo completoValidation Engineer II Responsibilities Completes projects as assigned by the department manager. Must be able to prioritize responsibilities and establish timelines in order to maintain a balance of support in all projects and execute projects with clear objectives. Generates and revises validation protocols SOPs drawings equipment specifications...
-
Validation Engineer 2
hace 3 días
Reynosa, México Fresenius Medical Care A tiempo completoValidation Engineer II Responsibilities Completes projects as assigned by the department manager. Must be able to prioritize responsibilities and establish timelines in order to maintain a balance of support in all projects and execute projects with clear objectives. Generates and revises validation protocols SOPs drawings equipment specifications...
-
Validation Engineer II
hace 4 días
Reynosa, México Fresenius Medical Care A tiempo completoA leading medical equipment company is seeking a Validation Engineer II in Reynosa, Tamaulipas. The role involves generating validation protocols and ensuring compliance with various standards, including FDA regulations. Candidates should hold a bachelor's degree in a relevant engineering field and possess 2-5 years of experience. Bilingual proficiency in...
-
Validation Engineer II
hace 3 días
Reynosa, México Fresenius Medical Care A tiempo completoA leading medical equipment company is seeking a Validation Engineer II in Reynosa, Tamaulipas. The role involves generating validation protocols and ensuring compliance with various standards, including FDA regulations. Candidates should hold a bachelor's degree in a relevant engineering field and possess 2-5 years of experience. Bilingual proficiency in...
-
Quality Systems Validation Engineer I
hace 2 semanas
Reynosa, México Fresenius Medical Care A tiempo completoQuality Systems Engineer I A leading medical device company is seeking a Quality Systems Engineer I to support the development and improvement of quality processes. Candidates should have a Bachelor's degree, bilingual skills in English and Spanish, and knowledge of FDA regulations and process validation. This full-time role requires strong problem-solving...
-
Validation Engineer: Test Equipment
hace 5 días
Reynosa, México Rhian_Convatec A tiempo completoA global medical products company in Reynosa is seeking a Validation Engineer for a 1-year contract. The role involves validating processes and equipment while collaborating with QA, Regulatory Affairs, and other departments. Candidates should possess a Bachelor’s in Industrial Engineering and have around 2 years of experience in validation processes....
-
Validation Engineer: Test Equipment
hace 5 días
Reynosa, México Rhian_Convatec A tiempo completoA global medical products company in Reynosa is seeking a Validation Engineer for a 1-year contract. The role involves validating processes and equipment while collaborating with QA, Regulatory Affairs, and other departments. Candidates should possess a Bachelor’s in Industrial Engineering and have around 2 years of experience in validation processes....
-
Quality Systems
hace 2 semanas
Reynosa, México Fresenius Medical Care A tiempo completoA leading medical device company is seeking a Quality Systems Engineer I to support the development and improvement of quality processes. Candidates must have a Bachelor's degree, be bilingual in English and Spanish, and possess a strong understanding of FDA regulations and process validation. This full-time role offers opportunities for career growth in a...
-
Quality Systems
hace 2 semanas
Reynosa, México Fresenius Medical Care A tiempo completoA leading medical device company is seeking a Quality Systems Engineer I to support the development and improvement of quality processes. Candidates must have a Bachelor's degree, be bilingual in English and Spanish, and possess a strong understanding of FDA regulations and process validation. This full-time role offers opportunities for career growth in a...
-
Validation Technician
hace 1 semana
Reynosa, México Corning A tiempo completo**Date**:Feb 4, 2025 **Location**: Reynosa, TAM, MX, 88700 Reynosa, TAM, MX, 88700 **Company**:Corning Requisition Number: 66256 Corning is vital to progress - in the industries we help shape and in the world we share. We invent life-changing technologies using materials science. Our scientific and manufacturing expertise, boundless curiosity, and...
