Kneat CSV Validation Specialist

HR Works; Las Piedras (PR); On-site; USD 60,000 - 90,000; Full time

Job summary

HR Works in Las Piedras, Puerto Rico, seeks a Validation / CSV Specialist to support validation in a regulated pharmaceutical environment. The role requires roughly 2–3 years of hands-on validation experience with Kneat.

You will work with cross-functional teams to ensure compliant validation documentation and lifecycle activities. The ideal candidate will hold a technical Bachelor’s degree and be fluent in English and Spanish, with strong documentation and analytical skills.

Qualifications

• Bachelor’s degree in engineering, science, IT, or related field.
• 2–3 years of validation experience in regulated industry.
• Hands-on Kneat experience required; strong documentation practices.

Responsibilities

• Support development, execution, review, and approval of validation docs and protocols.
• Use Kneat to create, manage, execute, route, and maintain validation records.
• Support validation activities for CSV-related systems, equipment, utilities, and processes.
• Execute and document IQ, OQ, and PQ protocols as applicable.
• Assist with CSV activities throughout system lifecycle.
• Ensure validation activities comply with FDA, GMP, SOPs, and standards.
• Review docs for accuracy, traceability, and regulatory compliance.
• Prepare and maintain validation plans, protocols, reports, specs, trace matrices.
• Collaborate with Engineering, Quality, Manufacturing, Automation, IT, and others.
• Identify discrepancies and document resolutions during protocol execution.
• Support investigations, change controls, CAPA, and related activities.
• Participate in validation project meetings and provide updates.
• Ensure docs are completed per project schedules and quality requirements.
• Contribute to continuous improvement of validation processes.

Skills

Validation knowledge

GMP/FDA awareness

Documentation skills

Analytical thinking

Communication skills

Bilingual Spanish/English

Education

Bachelor’s Degree in Engineering/Science/IT

Tools

Kneat

CSV best practices

Job description

HR Works in Las Piedras, Puerto Rico, seeks a Validation / CSV Specialist to support validation in a regulated pharmaceutical environment. The role requires roughly 2–3 years of hands-on validation experience with Kneat.

You will work with cross-functional teams to ensure compliant validation documentation and lifecycle activities. The ideal candidate will hold a technical Bachelor’s degree and be fluent in English and Spanish, with strong documentation and analytical skills.