Hello,
I hope youโre doing well.
My name is Jayadev, and Iโm reaching out from Intellectt Inc. regarding an exciting contract opportunity for a Equipment & Utilities Validation Engineer/Utility Qualification Engineer based in Maryland (Onsite) ย 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 ย jayadev.g@intellectt.com
ย
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 ย (732)-997-6982 ย Ext: 308
Email jayadev.g@intellectt.com