Validation Engineer

Company: Joul--
Location: Paulsboro
Posted on: May 1, 2025

Job Description:

Job Title: Validation Engineer

In order to make an application, simply read through the following job description and make sure to attach relevant documents.
Location: West Deptford, NJ
Type: Direct Hire (Full-Time)

Overview
A leading manufacturing organization specializing in regulated industries such as pharmaceuticals and biotech is hiring a Validation Engineer. This position offers the opportunity to lead critical validation projects and be the subject matter expert during audits. If you have a passion for validation and compliance in an API manufacturing environment, we encourage you to apply!

Responsibilities

Manage the full validation lifecycle, including planning, execution, documentation, and review
Develop, write, and execute validation protocols (IQ/OQ/PQ) for new equipment installations
Coordinate protocol execution, including Site Acceptance Testing with third parties and contractors
Regularly update and maintain Validation SOPs in alignment with best practices and regulatory requirements
Ensure thorough documentation of all validation activities to meet audit and compliance standards
Monitor and maintain compliance with FDA regulations, cGMP, ISO standards, and internal quality systems
Provide training on validation processes and compliance to internal teams
Act as SME for equipment validation during customer audits


Requirements Minimum 5 years of validation experience within a regulated industry (pharmaceutical, biotech, or medical device)
Strong expertise in validation protocol development, execution, and documentation
Familiarity with cGMP, FDA regulations, and ISO standards (including 21 CFR 11, 21 CFR Part 820, ICH Q7, ICH Q9, and ICH Q10)
Experience with API manufacturing processes - REQUIRED
Proficient in validation software and tools
Knowledge of DeltaV preferred
Bachelor's Degree in Engineering, Life Sciences, or a related field
Must be legally authorized to work in the United States for any employer

#M3
#LI-MM1
Ref: #558-Scientific

Keywords: Joul--, Wilmington , Validation Engineer, Engineering , Paulsboro, Delaware