Validation Engineer

Joulé • Paulsboro, NJ, US

Hace 15 días

Tipo de contrato

A tiempo completo

Indefinido

Descripción del trabajo

Job Title : Validation Engineer

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

Job Title : Validation Engineer

Location : West Deptford, NJ

Type : Direct Hire (Full-Time)

Overview

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

Ref : #558-Scientific

Seniority level

Mid-Senior level

Employment type

Contract

Job function

Quality Assurance

Industries

Staffing and Recruiting

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Validation Engineer • Paulsboro, NJ, US