Validation Engineer II
Posted on: January 15, 2019
Provide instrument validation support for QC analytical instruments after the move. The following validation deliverables must be completed by the Validation analyst according to Client procedural requirements and GMP guidelines Extensive knowledge and practical application of relevant techniques " working with variety of QC laboratory analytical instrumentation [e.g., High Performance Liquid Chromatography, Gas Chromatography, variety of Spectrophotometers (UV-Vis, NIR, AAS, ICP, Plate Readers), Capillary Electrophoresis, imaging Capillary Electrophoresis, and others)] and familiarity with other laboratory applications (e.g., SoftMax pro, ImageLab, UV Probe, UV WinLab) is a plus.. Demonstrated ability to be a self starter, excellent documentation practice, and troubleshooting laboratory instruments skills of high levels of complexity. Proficiency with Empower, Labware LIMS, Quality Tracking System (QT, MS Word Office Suite, and cGMP (CFR 211, ICH, Annex 15) experience. Candidate must be detailed oriented with strong verbal and written communication skills (e.g., technical and legible writing skills, validation documents and etc.). Ability to work well in a team environment. Strong independent work skills to meet established deliverables. Acquired/trained/certified (skill based training according to PGS Quality procedures and policies) to perform QC laboratory instruments requalification, calibration and performance verification after the instrument move. Performs all work in compliance with cGMPs, Quality, and Safely according to site requirements. Initiate, execute, track Change Controls as needed per laboratory requirements. Create and execute test plan according to an approve implementation plan from Quality Tracking System (QTS). Performs and documents instrument requalification, calibration and performance verification after the move according to approved procedures. Prepare laboratory reagents for use in instrument performance verification/calibration testing. Appropriately documents analytical testing following Data Integrity ALCOA guiding principles. Will use Empower Software to perform instrument Calibration and Performance Verification. Document all work using LabWare LIMS. Attentive to details and right first time. Ensures that work area is maintained in a neat, safe, orderly, and compliant manner. Validation Analyst Educational Attainment and Experiences:
Keywords: WSIT, Boston , Validation Engineer II, Engineering , Andover, Massachusetts
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