Validation & Engineering Group
LL01-250714 Validation Specialist for Packaging Equipment
Validation & Engineering Group, Caguas, Puerto Rico, United States, 00725
Validation Specialist For Packaging Equipment
Validation & Engineering Group, Inc. (V&EG) is a leading services supplier who provides solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in the following areas: Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services. We are seeking a talented, dedicated individual committed to work under the highest ethics standards for the following position: Validation Specialist for Packaging Equipment Qualifications: Bachelor's Degree in Science or Engineering. Minimum of 3 years of experience in direct pharmaceutical, medical device or biotechnology industries. Experience in direct process / manufacturing areas. Must be fully bilingual (English / Spanish) with excellent oral skills. Must be proficient using MS Windows and Microsoft Office applications. Strong knowledge in cGxP and regulatory guidance as well as understanding of how they are applied to regulatory compliance. Experience in Design Documentation (URS, DS), IQ, OQ, PQ protocols development and execution, deviations and reports generation. SDLC, Risk Assessment, Data Integrity, Factory Acceptance Test (FAT) & Site Acceptance Test (SAT). Strong knowledge in: Material cleaning systems, Collaborative robots, EFD for lubrication process, Cognex vision system for inspection, Automated Box Erector, Zebra printers and label applicators, Cognex Vision system for labels inspection, Semi-Automatic Case Former and sealer, Checkweigher, Automated Palletizer (Collaborative robots), Stretch Wrapper. Technical Writing skills and investigations processes. Available to work extended hours, possibility of weekends and holidays.
Validation & Engineering Group, Inc. (V&EG) is a leading services supplier who provides solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in the following areas: Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services. We are seeking a talented, dedicated individual committed to work under the highest ethics standards for the following position: Validation Specialist for Packaging Equipment Qualifications: Bachelor's Degree in Science or Engineering. Minimum of 3 years of experience in direct pharmaceutical, medical device or biotechnology industries. Experience in direct process / manufacturing areas. Must be fully bilingual (English / Spanish) with excellent oral skills. Must be proficient using MS Windows and Microsoft Office applications. Strong knowledge in cGxP and regulatory guidance as well as understanding of how they are applied to regulatory compliance. Experience in Design Documentation (URS, DS), IQ, OQ, PQ protocols development and execution, deviations and reports generation. SDLC, Risk Assessment, Data Integrity, Factory Acceptance Test (FAT) & Site Acceptance Test (SAT). Strong knowledge in: Material cleaning systems, Collaborative robots, EFD for lubrication process, Cognex vision system for inspection, Automated Box Erector, Zebra printers and label applicators, Cognex Vision system for labels inspection, Semi-Automatic Case Former and sealer, Checkweigher, Automated Palletizer (Collaborative robots), Stretch Wrapper. Technical Writing skills and investigations processes. Available to work extended hours, possibility of weekends and holidays.