Senior Validation Engineer ID 2026-0151

conexionlaboralsurestepr; Juncos (PR); On-site; USD 90,000 - 140,000; Full time

Job summary

conexionlaboralsurestepr is seeking a qualified professional to lead commissioning and qualification activities in a regulated manufacturing environment in Puerto Rico. You will plan, schedule, and manage resources for C&Q programs, ensuring compliance with GMP, FDA/EMA guidelines, and data integrity standards.

The role requires strong technical writing in English and Spanish, plus the ability to coordinate cross-functional teams in a fast-paced setting.

Qualifications

• Master’s degree in Engineering with 2 years of related experience, or a BS with 4 years in pharma or regulated manufacturing.
• Experience leading C&Q strategies, planning, scheduling and resource management in GMP environments.
• Proficient in data analysis and strong technical writing in English and Spanish.

Responsibilities

• Lead commissioning and qualification strategies, execution, and documentation in GMP settings.

Skills

C&Q leadership

GMP regulatory knowledge

Data analysis

Technical writing (EN/ES)

Education

Master's degree in Engineering

BS in Engineering +4 years experience

Job description

REQUISITOS

• Master’s degree in Engineering and 2 years of directly related experience OR BS degree in Engineering and 4 years of directly related experience in pharmaceutical, biotechnology, or other
  regulated manufacturing industry.
• Experience leading Commissioning & Qualification (C&Q) strategies, planning, scheduling, and resource management in GMP environments. Strong expertise in FAT, SAT, startup, field
  commissioning, and IQ/OQ/PQ execution. Knowledge of ASTM E2500, ISPE guidance, risk assessments, and qualification lifecycle management. Experience authoring, reviewing, and approving qualification protocols, validation reports, and technical documentation. Strong understanding of GMP, FDA/EMA regulations, Data Integrity (ALCOA+), Change Controls, Deviations, and CAPA.
• Proficient in data analysis and strong technical writing skills in English and Spanish.