Validation Engineer

For Validation Engineering services in the Utility Systems in the Manufacturing area.

About Flexible & Integrated Technical Services, LLC

• 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 take on this new challenge?

• We are a Service Provider company different from the rest.
• We pride ourselves in how we treat the most important piece of our company's puzzle: you!
• We integrate Engineering, Construction, Maintenance, Utilities and Specialized Technical services across the Island (and in the US as well!).
• Our company is flexible, family-oriented and focused on our resources' well-being, while providing our Pharmaceutical, Medical Device and Manufacturing industry clients with top-notch quality talent.
• We're FITS!
• Are you the next piece?

Responsibilities

• Developing, executing, and reviewing validation protocols and documentation.
• Change Controls, SOPs, deviations, and GMP documentation.
• AS A PIECE OF FITS, YOU WILL: (The day-to-day on the job) Develop, execute, review, and maintain validation protocols and documentation for utility systems and associated equipment.
• Execute and support IQ, OQ, and PQ activities, ensuring systems operate within established specifications and qualified parameters.
• Evaluate utility systems and equipment to identify validation gaps, compliance needs, and qualification requirements.
• Support Change Controls and assess validation and requalification requirements associated with equipment or system modifications.
• Develop and review SOPs, validation reports, protocols, and other GMP documentation.
• Support investigations, corrective actions, and ongoing compliance activities related to validated utility systems.
• Collaborate with Engineering, Quality, Manufacturing, and other technical teams to support validation and qualification activities.

Requirements

• The Technical Part: Bachelor’s Degree in Engineering or related field and three (3) to five (5) years of exposure to Validation activities within the regulated industry.
• English and Spanish Shift: Administrative and according to business needs.
• Hands-on validation experience with utility systems, including Compressors, Chillers, Air Handling Units (AHUs)/Exhaust Fans (EFs), and Generators .
• Supporting equipment qualification activities, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
• Perform qualification activities for Compressors, Chillers, AHUs/EFs, Generators, and related manufacturing utilities.