Validation Engineer

Indotronix International Corp

Posted Under: Providence, Rhode Island jobs in Engineering; Engineering jobs in zipcode 2901
Posted On: 2020-08-03 00:00:00

Position Validation Engineer Location Providence, RI (must sit onsite 2-3 days per week) Duration 6 months Qualifications B.S. M.S. in Computer Science or another relevant engineering discipline. Minimum of 5+ years of experience working within regulated manufacturing. Direct experience with CSV of GxP systems is mandatory. Demonstrated knowledge of cGMP manufacturing as well as regulatory regulations and requirements for medical devices, biotechnology, and pharmaceuticals with an emphasis on 21 CFR Part 11, including Annex 11, and Data Integrity. Experience in the areas of Design Documentation (URS, FRS, DS, and other engineering specifications), Validation (IQ, OQ, PQ, MVP, etc.), Quality Systems (Change Control, Non-Conformances, Requalification, etc) Familiarization with ISO 13485 and 21 CFR 820. Proficient in Microsoft Word, Excel, PowerPoint. Must be able to work independently with adequate supervision, multi-task, and support several projects simultaneously. Must demonstrate strong verbal, written, presentation, interpersonal and teamwork skills. Additional Requirements Candidates may be subject to background check and drug test.SDL2017