Project Validation Specialist

Flexible & Integrated Technical Services, LLC • Añasco, PR

4d • Onsite

About The Position

For Project Validation services in the Manufacturing area. Our Next Piece is someone who treats everyone they meet like family, especially our resources, clients and team members. In other words, being a customer service pro is one your (many) talents. Being the Piece means you're full of bright ideas and eager to innovate, always bringing top-quality results to the table. Are you ready to take on this new challenge?

Requirements

• Bachelor’s Degree in Engineering or Science
• At least five (5) years of exposure to Validation Engineering activities within the Pharmaceutical or Medical Devices industry.
• Bilingual (Spanish and English)
• Experience in EU MDR and Medical Device Documentation
• Experience in Gap Assessments and Compliance Reviews
• Experience in Execution of Remediation and Validation Activities

Responsibilities

• Participate in the discovery and compilation of required documentation to be evaluated.
• Assess of all manufacturing documentation such as product device master record (drawings, specifications, bill of materials, production router/instructions, procedures, labeling), process flow charts, incoming inspections, in-process inspections, final inspections, validation plans and process validations, among others.
• Perform tasks identified as part of the remediation plan including, but not limited to: validation documentation generation and execution (change control, validation plans, validation protocols, validation closure reports, technical.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level