Kneat CSV Validation Specialist

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

Job summary

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

The role focuses on developing, executing, and reviewing validation documentation, ensuring GMP and FDA compliance, and collaborating with cross-functional teams throughout the system lifecycle. Bilingual Spanish/English preferred.

Qualifications

• Bachelor’s Degree in Engineering, Science, Information Technology, or a related technical field.
• Approximately 2–3 years of experience in validation within the pharmaceutical, biotechnology, medical device, or other regulated industry.
• Hands-on experience using Kneat for validation activities is required.
• Knowledge of validation methodologies and documentation practices.
• Experience executing or supporting IQ/OQ/PQ protocols.
• Knowledge of CSV principles is highly desirable.
• Understanding of GMP and FDA-regulated environments.
• Familiarity with validation lifecycle documentation, including protocols, reports, requirements, specifications, and traceability documentation.

Responsibilities

• Support development, execution, review, and approval of validation documentation and protocols.
• Utilize Kneat to create, manage, execute, route, and maintain validation documents and records.
• Support validation activities related to computerized systems, equipment, utilities, manufacturing systems, and/or processes.
• Execute and document validation protocols, including IQ, OQ, and PQ, as applicable.
• Assist with Computer System Validation (CSV) activities throughout the system lifecycle.
• Collaborate with Engineering, Quality, Manufacturing, Automation, IT, and other cross-functional teams during validation activities.
• Assist in identifying and documenting discrepancies or deviations encountered during protocol execution.
• Support investigations, change controls, CAPAs, and other quality-related activities associated with validated systems or processes.

Skills

Validation experience

Kneat

IQ/OQ/PQ

CSV

GMP/FDA

Bilingual

Education

Engineering/Science/IT degree

Tools

Kneat

Job description

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

The role focuses on developing, executing, and reviewing validation documentation, ensuring GMP and FDA compliance, and collaborating with cross-functional teams throughout the system lifecycle. Bilingual Spanish/English preferred.