GxP Validation Specialist I

OcyonBio, LLC; Aguadilla (PR); On-site; USD 42,000 - 64,000; Full time

Job summary

OcyonBio is seeking an entry-level Validation Associate in Aguadilla, PR to support the Quality – Validation & Qualification function. You will assist with planning, documentation, execution, and closure of qualification and validation activities for equipment, facilities, utilities, and regulated systems, under guidance.

You will develop foundational validation skills, maintain GDP-compliant records, and collaborate with cross-functional teams to ensure compliant, traceable results.

Qualifications

• Bachelor’s degree in a technical field (engineering, life sciences, CS, IS) or related discipline.
• Familiarity with validation/qualification concepts like IQ/OQ/PQ is preferred.
• Experience or internships in regulated manufacturing is a plus.

Responsibilities

• Draft, revise, route, and organize validation documents (plans, URS, specs, risk assessments, protocols, trace matrices).
• Compile source information, vendor docs, test records, and evidence for review.
• Address comments and maintain version control and status tracking.

Skills

Validation concepts

GDP/ALCOA+ data integrity

Technical writing

Regulatory awareness

Documentation control

Education

Bachelor’s degree in Engineering, Life Sciences, Computer Science, Information Systems, or related technical discipline

Job description

OcyonBio is seeking an entry-level Validation Associate in Aguadilla, PR to support the Quality – Validation & Qualification function. You will assist with planning, documentation, execution, and closure of qualification and validation activities for equipment, facilities, utilities, and regulated systems, under guidance.

You will develop foundational validation skills, maintain GDP-compliant records, and collaborate with cross-functional teams to ensure compliant, traceable results.