Validation Engineer-Parsippany, NJ-Onsite

[David Miller]

Role: Validation Engineer

Location: Parsippany, NJ

Duration: 6+ months Contract with possible extension

 

Role Overview

Seeking a mid‑ to senior‑level Validation Engineer to support commissioning and qualification (CQV) activities in a pharmaceutical manufacturing environment. This resource will own IQ, OQ, and PQ protocol authoring and execution for equipment, utilities, packaging, and facility systems while ensuring cGMP and regulatory compliance.

This role requires someone who can work independently, lead validation efforts, partner cross‑functionally, and drive projects to completion.

 

Must‑Haves

• Authored and executed Commissioning, Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols.
• Supported qualification of process equipment, packaging lines, laboratory equipment, utilities, and facility systems.
• Performed temperature mapping studies for controlled temperature equipment and storage areas.
• Supported cleanroom and room qualification activities.
• Executed or supported media fills (aseptic process simulations) and smoke studies.
• Supported Environmental Monitoring (EM) studies.
• Investigated and documented deviations encountered during qualification activities.
• Prepared validation documentation and summary reports.
• Worked cross-functionally with internal teams (i.e., Engineering, Quality, Manufacturing, Supply Chain, and Validation) to support qualification activities and ensure project timelines are met.