Validation Engineer

The Validation Engineer is responsible for commissioning and qualification of processes and manufacturing equipment. Key responsibilities include ensuring the presence of a clear User Requirement Specification, achieving knowledge of product and process design, contributing to the selection of technical solutions, and maintaining relevant documentation throughout the project.

Requirements

• Degree in relevant discipline
• Experience with ISO 13485 and FDA requirements
• Act with integrity and escalate issues when company strategic interest or compliance are at risk
• Comprehension of the Validation life cycle and how it can be applied efficiently and remain compliant on local level
• Experience with equipment, process, mold and/or design Validation
• Understanding of Good Manufacturing Practice (GMP), current Good Automated Manufacturing Practice (cGAMP), and Quality Systems in a regulated environment
• Ability to communicate effectively with individuals at site levels and provide a proactive approach to solving problems
• Full understanding of testing requirements, product and material specifications, drawings, and related documentation to ensure compliance

Benefits

• Generous Paid Time Off
• 401k Matching
• Retirement Plan
• Relocation Assistance