Validation & Engineering Group, Inc.
LL01-062025 Validation Specialist for Biotech and Aseptic Process
Validation & Engineering Group, Inc., Juncos, Juncos, us, 00777
LL01-062025 Validation Specialist for Biotech Site
Validation & Engineering Group, Inc. (V&EG) is a leading service provider offering solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries. Our services include Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and more. We are seeking a dedicated Validation Specialist who adheres to the highest ethical standards to join our team. Qualifications
Bachelor's Degree in Science or Engineering Minimum of 5 years of experience in pharmaceutical, medical device, or biotechnology industries Experience in qualification and validation of facilities, utilities, drug substances, filling, inspection, and packaging areas for the Biotechnology industry Fully bilingual in English and Spanish with excellent oral communication skills Proficient in MS Windows and Microsoft Office applications Strong knowledge of cGxP and regulatory guidance, with understanding of their application to compliance Experience in developing and executing Design Documentation (URS, DS), IQ, OQ, PQ protocols, deviations, and reports Knowledge of SDLC, Risk Assessment, Data Integrity, FAT, and SAT Experience with Kneat and CDOCs Technical writing skills and experience with investigations processes Availability to work extended hours, including weekends and holidays Seniority level
Mid-Senior level Employment type
Full-time Job function
Strategy/Planning and Information Technology
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Validation & Engineering Group, Inc. (V&EG) is a leading service provider offering solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries. Our services include Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and more. We are seeking a dedicated Validation Specialist who adheres to the highest ethical standards to join our team. Qualifications
Bachelor's Degree in Science or Engineering Minimum of 5 years of experience in pharmaceutical, medical device, or biotechnology industries Experience in qualification and validation of facilities, utilities, drug substances, filling, inspection, and packaging areas for the Biotechnology industry Fully bilingual in English and Spanish with excellent oral communication skills Proficient in MS Windows and Microsoft Office applications Strong knowledge of cGxP and regulatory guidance, with understanding of their application to compliance Experience in developing and executing Design Documentation (URS, DS), IQ, OQ, PQ protocols, deviations, and reports Knowledge of SDLC, Risk Assessment, Data Integrity, FAT, and SAT Experience with Kneat and CDOCs Technical writing skills and experience with investigations processes Availability to work extended hours, including weekends and holidays Seniority level
Mid-Senior level Employment type
Full-time Job function
Strategy/Planning and Information Technology
#J-18808-Ljbffr