Cleanroom Facilities & Utilities Validation Specialist (NJ) - Validation & Engineering Group : Job Details

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:

• 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 eperience in Facility Qualification?, FQ 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.