CSV & Validation Specialist (Kneat Expert)

HR Works; Gurabo (PR); On-site; USD 65,000 - 85,000; Full time

Job summary

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

You will work with cross‑functional teams to ensure compliance with GMP and FDA regulations, develop and review protocols, and maintain validation documentation throughout the system lifecycle.

Qualifications

• 2–3 years of validation experience in pharma/regulated industries.
• Experience with validation lifecycle and documentation practices.
• Strong written/verbal communication in English; Spanish desirable.

Responsibilities

• Support development, execution, review, and approval of validation documentation and protocols.
• Utilize Kneat to manage validation documents and records.
• Assist with IQ/OQ/PQ protocols and CSV activities.
• Ensure compliance with FDA regulations, GMP, and company SOPs.
• Collaborate with cross‑functional teams during validation projects.

Skills

Validation experience

Bilingual Spanish/English

Education

Bachelor’s Degree in Engineering/Science/IT or related field

Tools

Kneat

Job description

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

You will work with cross‑functional teams to ensure compliance with GMP and FDA regulations, develop and review protocols, and maintain validation documentation throughout the system lifecycle.