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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
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