Senior Validation Engineers

Duties: Provide technical leadership to perform quality assurance and validation in biopharmaceutical Facilities/Utilities, Laboratory, Packaging, Manufacturing, Warehouse QSIT environment; serve as Quality Compliance resource, representing QA on teams in support of assignments; involved in software design, testing and qualification of various GMP equipment under FDA regulation; provide guidance for automation analysis; manage SDLC for various Quality Control equipment’s using HP-ALM; create & monitor CAPA reports etc.; prepare, maintain, or review validation and compliance documentation; recommend resolution of identified deviations; interpret, compile and review QC data; analyze data from validation tests to determine whether systems & processes meet required criteria; develop and maintain databases for tracking test results, validation activities or validated systems; track & prioritize defects; similar duties; utilize HP ALM, Veeva Quality, eTMF, RIM, Suvoda, SharePoint, SAP ECC, Toad, EU Annex 11, PIC/S Guide, CFR 820, CFR 210 & CFR 211, JIRA, MS Visio, SQL, PLC/SADA, CARA, SAP ECC, CARA, etc..

Requirements: MS or foreign equivalent in Computer Science / IT / Engineering (any) / IS / Science / Related and 3 years of experience in quality control, compliance, and system validation using HP ALM (OR) BS or foreign equivalent in Computer Science / IT / Engineering (any) / IS / Science / Related AND 5 years of relevant progressive experience in quality control, compliance, and system validation using HP ALM.