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Validation Engineer
Validation EngineerJoulé • Paulsboro, NJ, US
Validation Engineer

Validation Engineer

Joulé • Paulsboro, NJ, US
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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

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

    Ref : #558-Scientific

    Seniority level

    Seniority level

    Mid-Senior level

    Employment type

    Employment type

    Contract

    Job function

    Job function

    Quality Assurance

    Industries

    Staffing and Recruiting

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