Validation Engineer

Flexible & Integrated Technical Services, LLC • Añasco, PR

3d • Onsite

About The Position

For Engineering 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 of 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 Be The Piece?

Requirements

• Bachelor’s degree in Engineering or related field
• At least one (1) year of experience within the Pharmaceutical & Medical Devices Industry.
• Bilingual: Spanish and English
• Excellent communication skills
• A positive attitude.
• Experience in Process validation and equipment qualification (IQ, OQ, PQ)
• Experience with FDA, ISO 13485, GMP, and quality system requirements
• Experience with CAPAs, NCRs, Change Controls, risk assessments, and root cause investigations

Responsibilities

• Develop and execute validation protocols and reports (IQ, OQ, PQ).
• Support manufacturing by troubleshooting process issues and implementing corrective actions.
• Lead root cause investigations using tools such as 5 Whys, Fishbone, and FMEA.
• Manage and support CAPAs, NCRs, Change Controls, and risk assessments.
• Analyze process data using statistical tools to drive process improvements.
• Ensure compliance with FDA, ISO 13485, GMP, and internal quality requirements.
• Collaborate with Manufacturing, Quality, R&D, and Engineering teams on validation and process improvement projects.
• Support equipment qualifications, process transfers, and new product introductions.
• Develop and maintain technical documentation, including protocols, reports, and SOPs.

What This Job Offers

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