Validation & Engineering Group, Inc.
LL01-100824 Validation Engineer (1-3 years of experience)
Validation & Engineering Group, Inc., Juncos, Juncos, us, 00777
Overview
Validation Engineer (1-3 years of experience) – San Juan, Puerto Rico. 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 areas of Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services. Responsibilities
Develop and execute Design Documentation (URS, DS), IQ, OQ, PQ protocols; generate deviations and reports. Contribute to SDLC activities, risk assessment, data integrity efforts, and Factory Acceptance Test (FAT) & Site Acceptance Test (SAT). Apply technical writing skills and investigation processes. Work extended hours as needed, including weekends and holidays. Qualifications
Bachelor's Degree in Science or Engineering. 1 - 3 years of experience in direct pharmaceutical, medical device, or biotechnology industries. Experience in direct process/manufacturing areas. Fully bilingual (English / Spanish) with excellent oral skills. Proficient with MS Windows and Microsoft Office applications. Strong knowledge of cGxP and regulatory guidance and understanding of applying them to regulatory compliance. SDLC, Risk Assessment, Data Integrity, FAT & SAT familiarity. Technical writing skills and investigation processes. Seniority level
Entry level Employment type
Full-time Job function
Strategy/Planning and Information Technology
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Validation Engineer (1-3 years of experience) – San Juan, Puerto Rico. 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 areas of Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services. Responsibilities
Develop and execute Design Documentation (URS, DS), IQ, OQ, PQ protocols; generate deviations and reports. Contribute to SDLC activities, risk assessment, data integrity efforts, and Factory Acceptance Test (FAT) & Site Acceptance Test (SAT). Apply technical writing skills and investigation processes. Work extended hours as needed, including weekends and holidays. Qualifications
Bachelor's Degree in Science or Engineering. 1 - 3 years of experience in direct pharmaceutical, medical device, or biotechnology industries. Experience in direct process/manufacturing areas. Fully bilingual (English / Spanish) with excellent oral skills. Proficient with MS Windows and Microsoft Office applications. Strong knowledge of cGxP and regulatory guidance and understanding of applying them to regulatory compliance. SDLC, Risk Assessment, Data Integrity, FAT & SAT familiarity. Technical writing skills and investigation processes. Seniority level
Entry level Employment type
Full-time Job function
Strategy/Planning and Information Technology
#J-18808-Ljbffr