Validation Engineer

1 month ago


New York, United States Novozen Healthcare LLC Full time

What You'll Do

o Commissioning Forms o C/Q/V Protocols and Summary Reports o Standard Operating Procedures o Impact Assessments o Specifications (URS/FRS/DDS) o FATS/SATs  Perform field/site activities including, but not limited to, the following: o Attend and witness FATs and SATs o Execution of commissioning forms and witnessing vendor start-up and testing. o Execution of C/Q/V protocols. o Walkdown and verification of system drawings (P&IDs, as-builts, etc.) o Compile data and prepare reports for completed C/Q/V activities including ETOPs, protocol data packages, etc. o Assist in deviation investigation and resolution of problems and issues encountered during field execution activities. o Witness and troubleshoot as needed.  Primary responsibilities include C/Q/V of equipment and systems, including CSV and automation.

Qualifications & Requirements:  Associates or Bachelor degree in related field preferred.  7+ years of relevant experience.  Proficiency with Microsoft Office applications (Word, Excel, Project, PowerPoint, etc.).  Leadership capabilities

Preferred Qualifications  General exposure and experience in a GMP/Validation discipline with a knowledge and understanding of pharmaceutical  Design/Build/Commission/Validation processes and how they relate to regulatory requirements and cGMP regulations within the E.U. and U.S. FDA.  Experience in Pharmaceutical, Biotech, Medical Device Design, Construction, Commissioning, Validation, or QA. Experience in writing and execution of PFC, FC, IQ, OQ, and PQ forms/protocols for GMP Utilities, Equipment, Systems, and Software.  Use of automation tools


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