Senior Validations Engineer

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

At Kelly® Engineering we’re passionate about helping you find a job that works for you. How about this one?

We’re seeking Senior Validations Engineer to work for one of our top Biotechnology Industry client at Juncos, PR.

Shift: Administrative shift (support a 24/7 manufacturing operations, some remote work is possible)

Why you should apply to be Senior Validations Engineer

• Competitive pay with biweekly direct deposit (W-2)
• Hands-on experience supporting critical manufacturing and quality systems in a leading biotechnology environment
• Collaborative, fast-paced, and dynamic workplace with growth opportunities
• Access to extensive training resources and career guidance
• Paid vacation, sick leave, holidays, and eligibility for a Christmas bonus (Must comply with minimum established requirements to qualify.)

This job might be an outstanding fit if you have the following requirements:

• MS 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 industrie
• Experience leading Commissioning & Qualification (C&Q) activities, including strategy development, planning, scheduling, and resource management for parenteral manufacturing processes, vision systems, device assembly, and packaging equipment (automatic and HMLV lines).
• Strong expertise in Factory Acceptance Testing (FAT), Site Acceptance Testing (SAT), startup, field commissioning, and IQ/OQ/PQ protocol execution.
• Working knowledge of ISPE guidance, risk assessment methodologies, and qualification lifecycle management.
• Strong understanding of validation lifecycle activities, including protocol development and execution, GMP compliance, FDA/EMA regulations, Data Integrity, Change Control, Deviations, and CAPA management.
• Proficiency in data analysis and technical report writing, with excellent verbal and written communication skills in both English and Spanish.

The Senior Validations Engineer leads complex engineering, commissioning, qualification, and validation initiatives for pharmaceutical manufacturing systems, equipment, and facilities. This role provides technical expertise in process optimization, troubleshooting, and capital projects while ensuring compliance with GMP and validation requirements. The engineer collaborates with cross-functional teams to deliver high-quality solutions that support operational excellence and new product introductions.

Helping you discover what’s next in your career is what we’re all about, so let’s get to work.