Validation & Engineering Group
LL01-250724 Cleanroom Facilities & Utilities Validation Specialist
Validation & Engineering Group, Raritan, New Jersey, United States, 08869
Job Opportunity
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. Position Available
We are seeking a talented, dedicated individual committed to work under the highest ethics standards for the following position: Cleanroom Facilities and Utilities Validation Specialist for Cell Therapy Facilities Qualifications
Bachelor's Degree in Science or Engineering. Minimum of 5 years of experience in direct Pharmaceutical, Cell Therapy or biotechnology industries. Experience in Cleanroom facilities qualification. 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, EMPQ protocols development and execution, deviations and reports generation. Must have experience in Facility Qualification, including AVS, Air Visualization (Smoke) Studies (AVS), and ISO Recovery Test following the ISO 14644-3 guidance for cleanrooms classified as Grade B and C, ref: ISO 14644-3:2019(E) Section B.4. Must have experience in EMPQ Static + Dynamic + engineering study wall down. 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. Position Available
We are seeking a talented, dedicated individual committed to work under the highest ethics standards for the following position: Cleanroom Facilities and Utilities Validation Specialist for Cell Therapy Facilities Qualifications
Bachelor's Degree in Science or Engineering. Minimum of 5 years of experience in direct Pharmaceutical, Cell Therapy or biotechnology industries. Experience in Cleanroom facilities qualification. 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, EMPQ protocols development and execution, deviations and reports generation. Must have experience in Facility Qualification, including AVS, Air Visualization (Smoke) Studies (AVS), and ISO Recovery Test following the ISO 14644-3 guidance for cleanrooms classified as Grade B and C, ref: ISO 14644-3:2019(E) Section B.4. Must have experience in EMPQ Static + Dynamic + engineering study wall down. Available to work extended hours, possibility of weekends and holidays.