Validation Engineer

The ideal candidate will perform a variety of validation activities to maintain the validation life cycle of laboratory instruments (e.g.,validation of new and legacy instruments, performance verification, calibration, software and hardware through change control, application support, LabWare interface and LabWare build creation).
Performs all work in compliance with cGMPs and site requirements
Perform instrument validation activities (creation and execution of validation documents, instruments performance verification, calibration, laboratory application support)
Prepare laboratory reagents for use in instrument performance verification/calibration
Write and/or revise standard operating procedures for laboratory instrumentation and maintenance
Write and/or revise computer related system validation documents (e.g., validation plan, test plan, requirements specification, qualification protocols, and validation summary reports)
Participate with Business Technology (BT) initiatives as applicable (e.g., DMS migration, firmware and software upgrade, serve as liason between QC labs and BT)
Collaborate with QC Lab Systems in interfacing laboratory instruments with LabWare Enterprise system and Labware build creation
Qualifications
BS in scientific discipline (e.g., Chemistry or Biology) or related field with 5-8 years or MS in Chemistry or Biology or related field with 3-5 years of industry experience, preferably in the pharmaceutical or biopharmaceutical industry
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)
Demonstrated ability to independently develop, document, validate, and troubleshoot laboratory instruments of high levels of complexity
Proficiency with Empower, Labware LIMS, and MS Word Office Suite
cGMP (CFR 211, ICH, Annex 15) experience
Familiarity with Enterprise System (e.g., Quality Tracking System), and other laboratory applications (e.g., SoftMax pro, ImageLab, UV Probe, UV WinLab, Empower) is a plus
Contact Details
Name: Mangesh Kanade
Email :

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