Validation / CSV 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

Position Overview

Want to be part of an innovative team in the pharmaceutical industry?

We are seeking a Validation / CSV Specialist to support validation activities within a regulated pharmaceutical manufacturing environment in Las Piedras, Puerto Rico.

The ideal candidate will have approximately 2–3 years of hands‑on validation experience and demonstrated experience working with Kneat, an electronic validation lifecycle management platform used to develop, execute, review, approve, and maintain validation documentation.

This position will support validation initiatives while ensuring compliance with applicable regulatory requirements, Good Manufacturing Practices (GMP), company procedures, and industry standards.

Key Responsibilities

• Support the 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.
• Ensure validation activities comply with applicable FDA regulations, GMP requirements, company SOPs, and validation standards.
• Review validation documentation for accuracy, completeness, traceability, and regulatory compliance.
• Support the preparation and maintenance of validation plans, protocols, reports, requirements specifications, traceability matrices, and supporting documentation.
• 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.
• Participate in validation project meetings and provide updates regarding assigned activities, deliverables, and timelines.
• Ensure validation documentation is completed according to established project schedules and quality requirements.
• Support continuous improvement initiatives related to validation processes and documentation.

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 Computer System Validation (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.
• Ability to identify validation discrepancies and support appropriate documentation and resolution.
• Strong organizational and documentation skills.
• Ability to work independently while collaborating effectively with multidisciplinary teams.
• Strong analytical and problem‑solving skills.
• Excellent verbal and written communication skills.
• Bilingual in Spanish and English preferred.

Preferred Experience

Experience in one or more of the following areas is highly desirable:

• Computer System Validation (CSV)
• Equipment or process validation
• Manufacturing systems
• Automation systems
• Pharmaceutical manufacturing
• Electronic validation lifecycle management systems
• Change Control, Deviations, and CAPA
• FDA 21 CFR Part 11 / Data Integrity requirements

Physical / Manufacturing Requirements

• Ability to work in both office and manufacturing/plant environments.
• Ability to stand, walk, bend, and perform routine activities within manufacturing areas.
• Ability to climb ladders or steps when required.
• Ability to lift items up to approximately 25 lbs.
• Ability to comply with all site safety and manufacturing requirements.

Work Location

Las Piedras, Puerto Rico

This position requires working within a regulated pharmaceutical manufacturing environment and collaborating closely with site Engineering, Quality, Manufacturing, Automation, and Validation teams.

Our client is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by applicable law.