Entry-Level Validation Specialist – GMP & Documentation

Biosimilar Sciences PR LLC; Aguadilla (PR); On-site; USD 42,000 - 58,000; Full time

Job summary

OcyonBio in Aguadilla, PR is seeking an entry-level Validation Associate to support planning, documentation, and execution of qualification/validation activities. You will work under guidance to develop foundational validation skills while maintaining compliant records in line with GDP, GMP, and risk-based principles.

The role reports to the Validation Team Lead or Manager and involves collaboration with QA, Engineering, IT, and Manufacturing.

Qualifications

• Bachelor’s degree in Engineering, Life Sciences, Computer Science, Information Systems, or a related technical discipline.
• 0–2 years of relevant experience; internships and cooperative education experience may be considered.
• Ability to follow written procedures, communicate clearly, maintain accurate records, and work effectively in a regulated team environment.
• Strong attention to detail, willingness to learn, and ability to complete tasks and training accurately and on schedule.
• Academic, internship, or work exposure to pharmaceutical, biotechnology, medical-device, or other regulated manufacturing operations is preferred.
• Familiarity with validation or qualification concepts, GMP, GDP, technical writing, and risk-based practices is preferred.
• Basic exposure to manufacturing equipment, laboratory instruments, utilities, automation, or computerized systems is preferred.

Responsibilities

• Assist with drafting, revising, routing, and organizing validation documents (plans, requirements, specs, risk assessments, test protocols, traceability matrices, reports).
• Compile source information, vendor documentation, test records, and supporting evidence for review.
• Address review comments and maintain version control and status tracking.
• Prepare for and support IQ/OQ/PQ and other validation tests under supervision.
• Execute test steps and record observations, results, and evidence.
• Identify and escalate discrepancies, gaps, or deviations promptly.
• Support compilation of test results for validation summaries.
• Assist with risk assessments and validation impact evaluations under guidance.
• Apply GDP and ALCOA+ data integrity principles to regulated records.
• Assist documentation for change controls, CAPAs, and requalification activities.

Skills

Documentation

GDP/ALCOA+

GMP basics

Education

Bachelor's degree in Engineering/Life Sciences/CS

Tools

IQ/OQ/PQ exposure

GMP systems

Job description

OcyonBio in Aguadilla, PR is seeking an entry-level Validation Associate to support planning, documentation, and execution of qualification/validation activities. You will work under guidance to develop foundational validation skills while maintaining compliant records in line with GDP, GMP, and risk-based principles.

The role reports to the Validation Team Lead or Manager and involves collaboration with QA, Engineering, IT, and Manufacturing.