Validation Specialist

Validation Specialist with a strong knowledge of injection molding processes to support the development, execution, and documentation of validation activities (Protocols, Tests, Reports).

• Familiarized with IQ, OQ and PQ validation phases for molds and equipment.
• IQ: Confirmation of Drawings (including mold attributes), Equipment, and Procedures (mold setup and operating), mechanical assessment of mold and equipment.
• Develop inspection programs and instructions for setup/positioning of tooling and parts.
• Assuring that all product development processes and relevant applicable documentation are executed according to the agreed Product Specific Design and Development Plans.
• Updating and defining Standard Operating Procedures (SOPs).
• Familiarized with Gage R&R methodology preferable.
• Preferably, familiarized with metrology equipment and methods such as calipers, micrometers, CMM, Programmable Vision Inspections Systems.

Requirements

• Bachelor in Science
• Experience in FDA regulated industry
• 5 years of experience performing validation lifecycle activities
• Technical writing skills
• Read, write, speak and understand English and Spanish