Validation Engineer
1 month ago
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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