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JOB DESCRIPTION

Responsibilities: Provide validation experience and guidance during equipment design, software design, build, debug, and qualification phases of a project. Write overall project quality (validation scope) plans. Organize, guide, and write requirement specifications 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. Organize, guide, and write qualification plans and protocols as necessary. Work through validation documentation in a timely manner to meet project schedules. Create validation summary reports. Provide input to address validation deviations and/or change requests and identify qualification requirements to ensure compliance to system’s current validated state and all cGxP's. 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. Develop pertinent document templates tailored to customer SOP’s.

• 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.
• 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. E
• 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.