Validation Engineer

This individual will define, execute, review/approve and summarize equipment, process, software, and facility validation documentation including investigations into failures. They will use quality engineering concepts to monitor, support, and critically review changes or issues to existing product lines and/or critical processes; review and approve appropriate controlled documentation; ensure data is reviewed and trends are investigated in a manner to ensure product quality. They will create process, equipment, software and facility validation plan/protocols and reports that are comprehensive, clearly written and technically sound; participate in risk identification and assessment actions for new/changed equipment and processes; provide technical consultation and validation status impact assessment for validated equipment, process, and software changes and investigations.Requirements: BS (Life Sciences or Engineering preferred) with 2-5 years of Validation or Quality Engineering experience. Experience with production process, software, facility and equipment validation activities in the medical device and/or pharmaceutical industry. Demonstrated ability to coordinate cross functional projects.