Company Description

****** Onsite role *****

Summary • Provide validation experience and guidance during equipment design, software design, build, debug, and qualification phases of a project. • Develop pertinent document templates tailored to customer SOP’s. • Write overall project quality (validation scope) plans. • Organize, guide, and write requirement specifications as necessary. • Organize, guide, and write qualification plans and protocols as necessary. • Review qualification/requalification packages for completeness and accuracy, sound rationale, compliance with validation policies. • Interface with internal and client validation and engineering teams to secure document approvals. • Oversee and execute validation qualifications at our facility and at the customer’s site. • Create validation summary reports. • Drive a quality approach into the organization, change control, and documentation for the equipment design, software, and documentation. •  Support all aspects of the Validation life cycle, from design through operation and improvement. Requirements: 3+ years performing validation activities. Experience in custom engineered solutions, Medical Devices, or Life Sciences is preferred. Experience working with electrical design drawings. Proficient in Microsoft Office. Experience working in a GAMP 5 based validation model preferred. Excellent presentation skills and ability to mentor without direct authority. Ability to work in a team environment. Self-starter, able to work with minimal guidance. Experience with Rockwell Automation PLC Control Systems is preferred. Experience debugging/working with custom machines is preferred. Educational experience: Bachelor of Science degree (B.S.) in Systems Engineering, Life Sciences, Electrical/Controls Engineering, or Quality Assurance, related experience or the equivalent of.

Additional Information

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