Cqv Engineer
Seattle, Washington, United States And Toronto, Ontario, Canada
As a CQV Engineer, I performed a variety of duties at multiple client sites. I was able to quickly switch between projects and learn the techniques needed to perform my duties.Location: Bothell (Seattle), WADuration of Assignment: 10 Months· Generated risk assessments for compliance with 21 CFR Part 11 for equipment including single use mixers with DeltaV/TruBio, fill control units, protein sampler, osmometers, FTIR, ultra-pure water generators, and spectrophotometers.· Reviewed procedures, qualifications, and machine capabilities to identify compliance gaps.· Worked with the team to provide solutions to compliance gaps.Location: Thornton (Denver), CODuration of Assignment: 7 Months· Performed a Performance Qualification on a new site WFI distribution system.· Sampled 24 valves daily during PQ and tested samples for conductivity, bioburden, endotoxin, total organic carbon, and chlorine.· Ensured testing conformed to or referenced: USP 84, EP 2.6.14, USP 643, EP 2.2.44 USP 61, and USP 645.Location: Seattle, WADuration of Assignment: 2 Months· Performed an electrical Installation and Operational Verification (IOV) on newly installed electrical lines in an office to laboratory conversion.· Worked with an electrician to test the new electrical connections and verify the electrical work was built as drawn.· Made corrections to the building drawings as needed.Location: Madison, WIDuration of Assignment: 2 Months· Developed and performed Installation and Operational Qualifications (IOQs) for newly installed equipment.· Performed the IOQ for a thermos cycler, 2 UV Vis analyzers, a multimode reader, and a microplate reader.