Process Validation Engineer

My name is Bipasa, and I'm reaching out from Intellectt Inc. regarding an exciting opportunity for a Process Validation Engineer based in Norfolk, NE

Job Summary
Seeking a Process Validation Engineer with strong hands-on experience in Process Validation, Equipment Qualification (IQ/OQ/PQ), medical device manufacturing, and change management. The ideal candidate will have experience with PLM Agile, Change Orders, DMCO, validation documentation, risk assessments, and FDA/ISO 13485 requirements.







Job Title: Process Validation Engineer
Location: Norfolk, NE
Work Arrangement: Onsite

Requirements

• Strong experience in Process Validation and Equipment Qualification (IQ/OQ/PQ).
• Hands-on experience with PLM Agile, Change Orders, and DMCO.
• Knowledge of medical device manufacturing processes.
• Experience with Change Control and Change Management.
• Understanding of FDA, ISO 13485, and Quality Management Systems (QMS).
• Experience with Risk Assessment/FMEA, Engineering Studies, and Validation Documentation.
• Strong documentation and project coordination skills.
• Ability to work effectively with cross-functional teams.
• Must be able to work onsite in Norfolk, NE.

Responsibilities

• Lead and execute Process Validation and Equipment Qualification (IQ/OQ/PQ) activities.
• Prepare and review Validation Plans, Protocols, Reports, Risk Assessments, and Engineering Studies.
• Support Change Management for Products (CMP) involving manufacturing processes, product design, and supplier changes.
• Coordinate documentation updates, reviews, approvals, and implementation.
• Collaborate with Engineering, Manufacturing, Quality, Supplier Quality, and Operations teams.
• Support manufacturing process improvements and compliance projects.
• Participate in manufacturing transfer projects.
• Support deviation investigations, CAPA, and change control implementation.
• Manage project timelines, identify risks, and support timely project execution.
• Ensure validation activities meet applicable regulatory and quality requirements.

Bipasa Swain
Sourcing Specialist
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