Validation Engineer - New York, United States - Novozen Healthcare LLC

Description

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