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Equipment & Utilities Validation Engineer/Utility Qualification Engineer

Intellectt INC

Maryland City, MD • On-site

Contractor

This job post has expired 1 day ago. Applications are no longer accepted.


Job description

Hello,
 
I hope you’re doing well.
 
My name is Jayadev, and I’m reaching out from Intellectt Inc. regarding an exciting contract opportunity for a Equipment & Utilities Validation Engineer/Utility Qualification Engineer based in Maryland (Onsite)  with one of our prestigious clients.
 
I would love to connect and discuss this opportunity in more detail. Please feel free to share your updated resume at  jayadev.g@intellectt.com
 

Job Title:Equipment & Utilities Validation Engineer/Utility Qualification Engineer
Location: Maryland (Onsite)

Job Summary

We are seeking an experienced Equipment & Utilities Validation Engineer to support qualification, validation, and commissioning activities in a GMP-regulated pharmaceutical or biotechnology environment.

Key Responsibilities

  • Execute and review IQ, OQ, and PQ protocols for equipment and utility systems.
  • Perform Commissioning, Qualification, and Validation (CQV) activities.
  • Prepare and review validation documents, protocols, reports, risk assessments, and validation plans.
  • Support qualification of HVAC, Purified Water (PW), Water for Injection (WFI), Clean Steam, Compressed Air, and Nitrogen systems.
  • Investigate deviations, CAPAs, change controls, and validation issues.
  • Work closely with Engineering, QA, Manufacturing, and Maintenance teams.
  • Support regulatory inspections and maintain FDA and cGMP compliance.
Requirements
  • Bachelor's degree in Engineering, Life Sciences, or a related field.
  • 5+ years of validation experience in pharmaceutical, biotech, or medical device industries.
  • Strong experience in Equipment Qualification (IQ/OQ/PQ), Utility Validation, HVAC Qualification, and CQV.
  • Knowledge of cGMP, FDA regulations, validation lifecycle management, deviations, CAPAs, and change controls.
Preferred Qualifications
  • Experience in sterile manufacturing, biologics, or aseptic processing.
  • Familiarity with Kneat, ValGenesis, TrackWise, Veeva, or similar validation systems.
  • Experience supporting FDA and regulatory audits.
Thanks Regards,
JAYADEV
Sourcing Specialist
Phone  (732)-997-6982   Ext: 308
Email jayadev.g@intellectt.com