Senior Validation Engineer

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