Senior Validation Engineer — Pharma & Biotech (FAT/IQ/OQ/PQ)

Veg Group; Cayey (PR); On-site; USD 65,000 - 90,000; Full time

Job summary

Validation & Engineering Group, Inc. is seeking a Validation Specialist/Engineer with hands-on experience in pharmaceutical equipment and utilities qualification.

The role focuses on developing and amending validation protocols, executing FAT/IQ/PQ activities, and delivering inspection-ready documentation. Candidates should have a BS in a related field, about 5 years of validation experience, and knowledge of GMP, CAPA, and regulatory expectations.

Qualifications

• BS in Engineering, Chemistry, Biology or related field.
• 5 years (±2) experience in validation of pharmaceutical equipment and utilities.
• Experience with FAT, IQ/OQ, and PQ execution; PQ for water systems preferred.
• Knowledge of GMP, validation lifecycle, protocol/report writing, and CAPA processes.
• Proficient with technical documentation tools and on-site work.

Responsibilities

• Review and amend validation protocols across equipment and utility systems.
• Plan and execute FAT (Factory Acceptance Test) activities and IQ for equipment.
• Plan and execute PQ (Performance Qualification) for DI water generation and distribution.
• Produce updated protocols, test scripts, execution records and final validation reports with deviations.

Skills

Validation experience

GMP knowledge

CAPA processes

Documentation

Stakeholder coordination

Communication skills

Bilingual English/Spanish

Education

BS in Engineering, Chemistry, Biology

Tools

MS Word

MS Excel

Job description

Validation & Engineering Group, Inc. is seeking a Validation Specialist/Engineer with hands-on experience in pharmaceutical equipment and utilities qualification.

The role focuses on developing and amending validation protocols, executing FAT/IQ/PQ activities, and delivering inspection-ready documentation. Candidates should have a BS in a related field, about 5 years of validation experience, and knowledge of GMP, CAPA, and regulatory expectations.