Asepsis, Biology, Biotech and Pharmaceutical, Change Control, Commissioning, Current Good Manufacturing Practice (cGMP), Equipment Validation, FDA (Food and Drug Administration), FDA Requirements, GMP (Good Manufacturing Practices), HVAC, Manufacturing, Medical Equipment, Process Validation, Quality Assurance, Regulations, Risk Analysis, Validation Documentation, Validation Plan, Water For Injection (WFI)
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