Colsh Consultants LLC.
Validation Engineer
Colsh Consultants LLC., Chicago, Illinois, United States, 60290
Strong Experience in Computer Systems Validation (CSV)
within the Pharmaceutical industry.Minimum Qualifications:Required Bachelor's degree in Pharmaceutical Science OR related field of study.Responsibilities:Schedule and plan equipment and process qualification workload to meet approved schedules.Handle multiple projects and be able to work independently as required.Develop GxP system lifecycle documentation, including Validation Plans, User Requirements Specifications, Functional Design Specifications, Configuration Specifications, Testing Protocols (IQ/OQ/PQ/VSR/Deviations), User Acceptance Testing, Traceability matrix, System and Validation reports, SOPs, Change Control Documentation, and Risk assessment/FMEA reports as required.Establish critical parameters, plan, design, and implement validation projects and protocols.Ability to author, execute, and thoroughly review complex protocols and documentation.Coordinate validation activities with other departments.Stay current with industry qualification trends through FDA, ISPE, EU and benchmarked companies.Consult, coordinate, and cross-function with various personnel within the company and externally.Have the ability to problem solve with minimal oversight, including conducting research to aid in the resolution of issues that arise.Train and mentor other Validation personnel as necessary.Determine and acquire necessary supplies and equipment for validation activities (Planning).Administer the site Change Control/Management Program.Make decisions representing QA in multi-functional teams.Plan and assist with the Global serialization project (as necessary).Familiarity and experience with TrackWise, LIMS, ComplianceWire, JDE, GAMP is desirable.
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within the Pharmaceutical industry.Minimum Qualifications:Required Bachelor's degree in Pharmaceutical Science OR related field of study.Responsibilities:Schedule and plan equipment and process qualification workload to meet approved schedules.Handle multiple projects and be able to work independently as required.Develop GxP system lifecycle documentation, including Validation Plans, User Requirements Specifications, Functional Design Specifications, Configuration Specifications, Testing Protocols (IQ/OQ/PQ/VSR/Deviations), User Acceptance Testing, Traceability matrix, System and Validation reports, SOPs, Change Control Documentation, and Risk assessment/FMEA reports as required.Establish critical parameters, plan, design, and implement validation projects and protocols.Ability to author, execute, and thoroughly review complex protocols and documentation.Coordinate validation activities with other departments.Stay current with industry qualification trends through FDA, ISPE, EU and benchmarked companies.Consult, coordinate, and cross-function with various personnel within the company and externally.Have the ability to problem solve with minimal oversight, including conducting research to aid in the resolution of issues that arise.Train and mentor other Validation personnel as necessary.Determine and acquire necessary supplies and equipment for validation activities (Planning).Administer the site Change Control/Management Program.Make decisions representing QA in multi-functional teams.Plan and assist with the Global serialization project (as necessary).Familiarity and experience with TrackWise, LIMS, ComplianceWire, JDE, GAMP is desirable.
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