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.