Validation Engineer
JouléPaulsboro, NJ, United States2 days ago
Job type
- Full-time
- Permanent
Job descriptionManage 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 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 Bachelors Degree in Engineering, Life Sciences, or a related field Must be legally authorized to work in the United States for any employer
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
Requirements
#M3
Ref : #558-Scientific
Seniority level
Seniority level
Mid-Senior level
Employment type
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Job function
Job function
Quality Assurance
Industries
Staffing and Recruiting
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Quality Assurance Engineering Specialist
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Validation Engineer • Paulsboro, NJ, United States
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