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Remote- Equipment & Utility Validation Engineer / Specialist

New York, NY, US • Posted 3 hours ago • Updated 3 hours ago

Contract Corp To Corp

Contract Independent

Contract W2

12 Months

No Travel Required

On-site

Depends on Experience

Fitment

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Job Details

Skills

Validation
CQV

Summary

Title: Equipment & Utility Validation Engineer / Specialist

Duration: 6+ months

Overview:
We are seeking highly experienced Equipment & Utility Validation Engineers/Specialists to support pharmaceutical and biotech manufacturing operations in a GMP-regulated environment. The ideal candidate will have strong expertise in commissioning, qualification, validation (CQV), and utility systems validation with hands-on experience in FDA-regulated facilities.

Key Responsibilities:

Execute equipment and utility qualification activities including IQ, OQ, and PQ
Develop, review, and execute validation protocols and reports
Perform commissioning and qualification (CQV) activities for manufacturing and utility systems
Validate clean utilities including WFI, RO, Clean Steam, HVAC, and compressed gases
Support deviation investigations, CAPA, change controls, and risk assessments
Ensure compliance with GMP, FDA, ISPE, and regulatory standards
Collaborate with Engineering, QA, Manufacturing, and Validation teams
Maintain accurate validation and compliance documentation

Required Skills:

Strong experience with Equipment & Utility Validation in Pharma/Biotech environments
Hands-on expertise with IQ/OQ/PQ and CQV processes
Knowledge of GMP/GxP compliance requirements
Experience with utility systems validation and process equipment qualification
Excellent documentation and communication skills
Ability to work independently in fast-paced regulated environments

Preferred:

Experience supporting FDA audits and inspections
Familiarity with Kneat, ValGenesis, or other validation management tools
Strong troubleshooting and analytical skills

Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.

Dice Id: 10513292
Position Id: 73093-12895-
Posted 3 hours ago

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