Validation & CSV Specialist – Kneat Expert

HR-Work; Gurabo (PR); On-site; USD 65,000 - 90,000; Full time

Job summary

HR-Work in Puerto Rico seeks a Validation / CSV Specialist to support validation activities in a regulated pharmaceutical manufacturing environment in Las Piedras. The ideal candidate will have 2–3 years of hands-on validation experience and knowledge of Kneat.

Responsibilities include developing, executing, and reviewing validation docs, performing IQ/OQ/PQ protocols, ensuring GMP/FDA compliance, and collaborating with Engineering, Quality, Manufacturing, and IT to drive compliant CSV

Qualifications

• Bachelor's degree in engineering, science, IT, or related technical field.
• 2–3 years of validation experience in regulated pharma/biotech/medical devices.
• Hands-on Kneat experience is required.
• Knowledge of IQ/OQ/PQ protocols and CSV principles.
• Understanding of GMP and FDA-regulated environments.
• Strong documentation and organizational skills.
• Bilingual in Spanish and English preferred.

Responsibilities

• Support development, execution, review, and approval of validation docs and protocols.
• Use Kneat to create, run, route, and maintain validation records.
• Support CSV activities for equipment, systems, and processes.
• Execute IQ/OQ/PQ protocols and document results.
• Ensure compliance with FDA, GMP, SOPs, and standards.
• Collaborate with Engineering, Quality, Manufacturing, IT, and others.
• Identify discrepancies and support resolutions.
• Assist with change controls, CAPAs, and investigations.

Skills

Validation experience

Kneat knowledge

IQ/OQ/PQ execution

Documentation skills

GMP/FDA awareness

English proficiency

Education

Bachelor's degree in Engineering/Science/IT or related field

Tools

Kneat

Job description

HR-Work in Puerto Rico seeks a Validation / CSV Specialist to support validation activities in a regulated pharmaceutical manufacturing environment in Las Piedras. The ideal candidate will have 2–3 years of hands-on validation experience and knowledge of Kneat.

Responsibilities include developing, executing, and reviewing validation docs, performing IQ/OQ/PQ protocols, ensuring GMP/FDA compliance, and collaborating with Engineering, Quality, Manufacturing, and IT to drive compliant CSV