Validation Engineer

Flexible & Integrated Technical Services, LLC • Ponce, PR

5d

About The Position

The Validation Engineer provides validation engineering services for utility systems in the manufacturing area. The role develops, executes, reviews, and maintains validation protocols and documentation, and performs qualification activities for manufacturing utilities and associated equipment. The engineer supports IQ, OQ, and PQ activities to confirm that systems operate within established specifications and qualified parameters, while helping identify validation gaps, compliance needs, and qualification requirements. The position also supports change controls, GMP documentation, investigations, corrective actions, and ongoing compliance in collaboration with Engineering, Quality, Manufacturing, and other technical teams. The stated shift is administrative and according to business needs.

Requirements

• Bachelor’s degree in Engineering or a related field.
• Three to five years of exposure to validation activities within a regulated industry.
• Bilingual in English and Spanish.
• Experience developing, executing, and reviewing validation protocols and documentation.
• Hands-on validation experience with utility systems, including compressors, chillers, air handling units (AHUs), exhaust fans (EFs), and generators.
• Experience supporting equipment qualification activities, including IQ, OQ, and PQ.
• Experience with change controls, SOPs, deviations, and GMP documentation.

Responsibilities

• Develop, execute, review, and maintain validation protocols and documentation for utility systems and associated equipment.
• Perform qualification activities for compressors, chillers, AHUs/EFs, generators, and related manufacturing utilities.
• Execute and support Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (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.

What This Job Offers

• Job Type: Full-time