Engineer

Flexible & Integrated Technical Services, LLC • Añasco, PR

14d • Onsite

About The Position

For Validation services in the Engineering & Manufacturing areas. 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
• Previous exposure to validation quality activities within the Pharmaceutical or Medical Devices industry.
• Bilingual, Spanish and English (good communication)
• SOP Development
• Validation Documentation
• GMP & GDP

Responsibilities

• Write, execute and maintain on a timely basis Validation protocols.
• Ensure timely, thorough and complete execution of all protocols, meeting FDA requirements.
• Ensure that all new and existing protocols are effectively integrated into manufacturing processes.
• Ensure documentation is thorough, accurate and entered on a timely basis into the quality system.
• Ensures complete and thorough investigation of all product failures, batch failures and deviations associated with validation sampling and testing.
• Develops documentation of investigations and communicates findings to ensure chance of recurrence is significantly minimized and resolution satisfies validation requirements.
• Responsible for developing and implementing process strategies, optimizing current processes, and maintaining process documents.
• Support the day to day process operations.

What This Job Offers

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