LabWare
From LabWare's careers page
Status: listed on the employer's own careers page when we last checked (daily). Confirm on their site before applying.
Position: Senior Validation Engineer
Reports to: Validation Practice Manager
Company: LabWare Global Services, Inc.
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.
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
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
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
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
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
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