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
Techical writting skills
Read write speak and understand English and Spanish
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