Validation Engineer -Kilkenny Contractor

This is a 6 – 9 month initial contract.

Responsibilities:

• Develop and maintain Quality System procedures.
• Investigate and troubleshoot validation issues related to components, equipment, and performance processes.
• Monitor and ensure the compliance status of quality records.
• Write, review, approve, and execute documentation for new and current validation procedures and technical reports for equipment, products, and processes.
• Assist in establishing corporate validation policies.
• Maintain the quality and compliance of Procedures, work instructions, and training materials.
• Track, communicate, and report on status, metrics, trends, potential issues, and improvement initiatives.
• Demonstrate in-depth understanding of design controls and design transfer.
• Participate in or lead risk analyses and FMEAs (Failure Mode and Effects Analysis).
• Interface with senior management on significant matters, coordinating activities across organizational units as needed.
• Mentor less-experienced staff and potentially supervise technical employees.

Qualifications:

• 5 plus years of experience in a similar role.
• Strong background in quality validation within a regulated industry.
• Experience with risk analysis, FMEAs, and design controls.
• Excellent documentation and communication skills.
• Ability to work collaboratively across teams and mentor junior staff.