Validation Engineer
CurrentProvide support for SOPs, qualification protocols, gap assessments, risk assessment, Impact Assessment, user requirements, functional and configuration specifications, requirements traceability, validation plans, validation summary reports and change controls. Execute protocol execution, documentation of results, deviations, and corrective actions, and preparation of Summary Reports, Trace Matrices and Summary Reports associated to validate computer systems.• Perform Gap Assessments and Remediation Plans with an understanding of applying risk management principles.• Ensure appropriate regulations, such as 21 CFR Part 11, 820 and cGMP regulations, are addressed in validation.• Provide training to colleagues and contractors on our approach to systems implementation and validation SOP's.• Assist validation activities of cross functional teams that include technical functions such as Information Systems, Manufacturing and QA Engineering.• Develop and maintain Validation SOPs, forms, documentation and files.• Good knowledge and skills in the engineering of Automation for HVAC/ Clean Media / Process Utility/Monitoring Building Management Systems.• GMP compliance knowledge including knowledge of 21 CFR Parts 11, 210, 211, and 820 requirements, Data Integrity, ICH Q7A requirements, and GMP.
