FDA Validation Engineer

About the role

Join us as an FDA Validation Engineer. This is an onsite position based in Nashville, TN.

Responsibilities

• Provide validation experience and guidance during equipment design, software design, build, debug, qualification and improvement phases of a project.
• Develop pertinent document templates tailored to customer SOP’s.
• Write overall project quality (validation scope) plans and validation summary reports.
• Organize, guide, and write requirement specifications.
• Oversee, execute and review qualification/requalification packages for completeness and accuracy, sound rationale, compliance with validation policies.
• 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.
• 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.

Requirements

• Bachelor’s degree in Electrical Engineering or equivalent experience, calculated as two (2) years of relevant work experience for each year of academic study.
• 3+ years performing validation activities in a Medical Device or Life Science environment preferred.
• Experience working in a GAMP 5 based validation model.
• Current or prior JR Automation experience, or experience in the automation industry is strongly preferred.
• Ability to understand electrical/pneumatic schematic drawings.
• Experience with PLC Control Systems preferred.
• Debugging skills preferred.

Qualifications

Note: This list of responsibilities is not inclusive; however, it is intended to be a guideline for activities.