Validation Engineer – Equipment & Utilities

Frederick, MD, US • Posted 8 hours ago • Updated 8 hours ago
Contract W2
Contract Independent
Contract Corp To Corp
12 Months
No Travel Required
On-site
Depends on Experience
Fitment

Dice Job Match Score™

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Job Details

Skills

  • Validation Engineer
  • Equipment & Utility
  • CQV

Summary

Title: Equipment & Utility Validation Engineer / Specialist

Location: Frederick, Maryland (Onsite) – Need Local or Nearby non-local accepted who can relocate at their own cost.

Duration: 6+ months

 

Job 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: 73088-12895-
  • Posted 8 hours ago
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