Validation Engineer

Joulé; Paulsboro (NJ); On-site; USD 70,000 - 100,000; Full time

Job summary

An established industry player in regulated manufacturing is seeking a Validation Engineer to lead critical validation projects in an API manufacturing environment. This role involves managing the full validation lifecycle, ensuring compliance with FDA regulations, and maintaining high-quality standards. The ideal candidate will have strong expertise in validation protocol development and a passion for compliance. This position offers a unique opportunity to make a significant impact in a dynamic and innovative setting. If you are dedicated to quality assurance and eager to contribute to vital projects, we encourage you to apply!

Qualifications

• 5+ years of validation experience in pharmaceuticals or biotech.
• Expertise in validation protocol development and documentation.

Responsibilities

• Manage full validation lifecycle including planning and execution.
• Develop and execute validation protocols for new equipment.

Skills

Validation Protocol Development

cGMP Compliance

FDA Regulations

ISO Standards Knowledge

API Manufacturing Processes

Education

Bachelor’s Degree in Engineering

Bachelor’s Degree in Life Sciences

Tools

Validation Software

DeltaV

Job description

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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