Senior Validations Engineer — GMP/QA Biotech Ops (Remote)

Kelly Science, Engineering, Technology & Telecom; Juncos (PR); Hybrid; USD 85,000 - 110,000; Full time

Benefits offered by this job

Biweekly direct deposit

Paid vacation and holidays

Christmas bonus eligibility

Extensive training resources

Job summary

Kelly Science, Engineering, Technology & Telecom is seeking a Senior Validations Engineer in Juncos, PR, to lead commissioning, qualification, and validation activities within a regulated pharma/biotech manufacturing setting. The role requires strong data analysis and bi-lingual communication (English/Spanish) to support GMP-compliant processes.

The Senior Validations Engineer will oversee FAT/SAT, IQ/OQ/PQ protocol execution, and collaboration with cross-functional teams to optimize processes

Qualifications

• MS or BS in Engineering with related pharma/biotech manufacturing experience.
• Experience leading commissioning & qualification (C&Q) activities for parenteral processes and equipment.
• Strong FAT/SAT startup and IQ/OQ/PQ protocol execution experience.
• Working knowledge of GMP, FDA/EMA regulations, Data Integrity, Change Control, Deviations, and CAPA.
• Proficiency in data analysis and technical report writing; fluent in English and Spanish.

Responsibilities

• Lead complex engineering, commissioning, qualification, and validation initiatives for pharmaceutical systems, equipment and facilities.
• Provide technical expertise in process optimization, troubleshooting, and capital projects.
• Collaborate with cross‑functional teams to ensure GMP compliance and successful product introductions.

Skills

Data analysis

Technical report writing

Bilingual English/Spanish

Communication skills

Project coordination

Education

MS degree in Engineering

BS degree in Engineering

Tools

FAT

SAT

IQ/OQ/PQ

Job description

Kelly Science, Engineering, Technology & Telecom is seeking a Senior Validations Engineer in Juncos, PR, to lead commissioning, qualification, and validation activities within a regulated pharma/biotech manufacturing setting. The role requires strong data analysis and bi-lingual communication (English/Spanish) to support GMP-compliant processes.

The Senior Validations Engineer will oversee FAT/SAT, IQ/OQ/PQ protocol execution, and collaboration with cross-functional teams to optimize processes