Validation Specialist

Flexible & Integrated Technical Services, LLC • Añasco, PR

1d • Onsite

About The Position

For Validation services in the Engineering 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 Life Sciences
• A minimum of three (3) years of exposure in Validation and Lean Manufacturing activities within the Pharmaceutical or Medical Device Industry.
• Excellent verbal/written communication skills (English and Spanish)
• Experience in Validation Protocols
• Experience in Lean Manufacturing
• Experience in GMP & GDP regulations

Responsibilities

• Write, execute, and maintain on a timely basis Validation protocol.
• 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