Senior Validation Engineer

Senior Validation Engineer 30+ days ago Requisition ID: 1008 Position: Senior Validation Engineer Reports to: Validation Practice Manager Company: LabWare Global Services, Inc. Location: Wilmington, DE Job Description LabWare Global Services (LGS) has an immediate opening for a Senior Validation Engineer. The successful candidate will participate and/or lead LabWare LIMS and ELN validation activates including the creation/execution of validation deliverables and management of a validation team. As much of LGS validation work is conducted remotely or at a customer facility, the position requires a minimum of 50% travel. Services Responsibilities and Expectations: Review and interpret functional requirements Create and execute IQ, OQ and PQ test plans and test scripts Identify and report test and system defects Create validation plans, schedules, requirements documents, configuration documents, trace matrices, and summary reporting documents Work with customer and technical consultants to define validation strategy based on best practices and GAMP Create validation work estimates for customer projects Lead requirements gathering process and conduct process analysis Interpret customer user requirements Conduct initial and complexity risk assessments Facilitate business risk assessments with customer Manage one or more validation resources Manage IQ, OQ and PQ test execution and verification of system defects Identify Regression testing needs Prepare operational procedures for customer systems Work with customer quality to ensure customer procedures are being adhered to Work with LGS Technical and Senior Staff Contribute to LabWare Validation Service process improvement Develop and maintain superior LabWare product knowledge Ability and willingness to work with a team Ability to work independently as well as part of a team Technical Skills: Proficiency in Microsoft Office products (PowerPoint, Word, Excel, Access) Proficiency in GAMP risk based testing guidance Strong understanding of 21 CFR Part 11 and Predicate rule Solid understanding of SDLC concepts Understanding of database concepts such as SQL, tables and fields Additional Requirements and Soft Skills: Bachelor’s degree or higher Minimum 4 years of work experience in a laboratory, IT setting, quality setting, or professional work environment or 2 years of LabWare product testing experience Experience is software testing is required Strong analytical and problem solving skills Attention to detail Excellent time management and follow through skills Outstanding organizational, writing and documentation creation skills Strong customer service skills Self-motivated Interpersonal and communication skills (verbal and written) Positive attitude, ability to motivate customers and establish credibility Ability to accommodate at least 50% overnight travel (interstate and country) and schedule flexibility Good Corporate Citizenship: Professionally represent LabWare at customer site (image and conduct) Achieve and retain LabWare Consultant Certification Maintain training record Dedicated LabWare employee Timely submission of Time/Expense/Status Reports