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Posted: Thursday, January 11, 2018 12:06 AM


Genesis Engineers, Inc.
Candidate will be responsible for validation and verification studies (FAT, SAT, IOQ, PQ) for cleaning, shipping, equipment, systems, utilities, and processes and ensure compliance with the relevant regulatory (local, state and federal) agencies. Writes, approves and executes protocols, resolves deviations/discrepancies, reviews and analyzes study data, writes and approves summary reports. Writes, reviews and revises a variety of installation, operation and performance qualification/verification related documents, including the following: SOPs, validation/verification master plans, guidelines and execution plans, automation, engineering design, commissioning, qualification or other technical documents, user requirement specifications (URS), basis of design documents (BOD), functional requirement specifications (FRS), detailed design specifications (DDS), factory acceptance test documents (FAT), verification protocols, and/or commissioning test procedures (CTP).

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Bachelor’s degree in Engineering, Science or equivalent technical discipline.
3-5 years experience in validation/verification services, in a regulated manufacturing environment, preferably in QA within the biotechnology, pharmaceutical, medical device industries.
Two or more years of direct equipment, systems or utilities validation/verification experience
Ability to read and interpret Piping and Instrument Diagrams (P&IDs) and electrical diagrams
Travel Required (Domestic/International)

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• Location: Philadelphia, Plymouth Meeting, PA

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