Validation Associate

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

Job Posting Title

Validation Associate

Job Description

Company: OcyonBio is a partnership development and manufacturing organization focused on advancing gene and cell therapies.

OcyonBio provides dedicated autonomous manufacturing capacity with interconnected infrastructure and systems to support phased appropriate development for early development, pre-clinical, clinical, and commercial start. We behave more like a cGMP incubator space with all regulatory, systems capabilities, and resources to enable CMC data to support regulatory applications. Manufacturing and development spaces are designed to be autonomous while being interconnected to systems required to support clinical and commercial requirements.

We strive to create a space free of both explicit and implicit discrimination and harassment where everyone feels safe, heard, and valued. The character of our employees is as important as their talent, and we’re proud of the team and environment we’re assembling as we grow.

Place of Performance: CII George Sanders, Aguadilla Pueblo, Aguadilla P.R. 00603.

Job Overview:

The Validation Associate provides entry-level technical and documentation support to the Quality – Validation & Qualification function. The position supports the planning, documentation, execution, and closure of qualification and validation activities for equipment, facilities, utilities, computerized systems, automation platforms, and other GxP-regulated systems, as assigned.

Working under close guidance from experienced validation personnel, the Associate develops foundational validation skills while maintaining compliant, accurate, and traceable records in accordance with approved procedures, Good Documentation Practices (GDP), applicable GMP requirements, and risk-based validation principles.

The position reports to the Validation Team Lead or Validation Manager, as assigned, and has no direct reports. Assignments are based on training, demonstrated competence, system complexity, and the applicable validation discipline. Validation strategy, independent technical decisions, risk acceptance, system release, and final approvals remain with authorized personnel.

Responsibilities

• Assist with drafting, revising, routing, and organizing validation documents, including validation plans, user requirements, specifications, risk assessments, test protocols, traceability matrices, and validation summary reports.
• Compile source information, vendor documentation, test records, and supporting evidence for review by qualified personnel.
• Address document review comments and maintain accurate version control and document status tracking.
• Prepare for and support the execution of approved Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), and other validation tests within completed training and assigned responsibilities.
• Execute defined test steps under appropriate supervision and record contemporaneous observations, results, and objective evidence.
• Identify and promptly inflate unexpected results, discrepancies, missing prerequisites, documentation gaps, and potential deviations.
• Assist with compiling test results and supporting information for validation and qualification summary reports.
• Support information gathering for system impact assessments, risk assessments, and validation impact evaluations under guidance.
• Apply GDP and ALCOA+ data integrity principles when creating or handling regulated records.
• Assist with documentation associated with change controls, discrepancies, deviations, Corrective and Preventive Actions (CAPAs), periodic reviews, and requalification activities.
• Maintain organized, accurate, and retrievable validation records in approved repositories and templates.
• Support tracking of open actions, protocol status, document approvals, and validation milestones.
• Collaborate with Validation, Quality Assurance, Engineering, IT, Automation, Manufacturing, Quality Control, and system owners to complete assigned tasks.
• Support interactions with vendors or contractors when assigned and supervised.
• Complete required GMP, GDP, safety, and role-specific training before performing controlled activities.
• Communicate progress, incorporate feedback, and demonstrate increasing knowledge and appropriate independence in assigned validation activities.
• Perform other related duties consistent with training, capability, and business needs, in accordance with applicable safety, GMP, and Quality System requirements.

Education / 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 assigned 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.

Technical Skills

• Foundational understanding of qualification and validation lifecycle activities, including IQ, OQ, and PQ.
• Ability to prepare accurate technical documentation and incorporate review comments under guidance.
• Ability to follow approved test procedures and collect complete, legible, traceable, and attributable evidence.
• Foundational knowledge of GDP and ALCOA+ data integrity principles.
• Ability to organize validation records, maintain document version control, and track assigned actions and deliverables.
• Ability to recognize discrepancies, communicate potential risks, and elevate issues promptly.
• Ability to develop working knowledge of applicable GMP, GAMP 5, 21 CFR Part 11, and EU Annex 11 principles relevant to assigned systems.
• Effective collaboration, status communication, and ability to learn through training and feedback.

Working Conditions

• Work is performed in office, laboratory, manufacturing, and project-support settings at a regulated GMP site.
• Entry into controlled areas may be required and is subject to applicable gowning, safety, and training requirements.
• Occasional support for scheduled execution outside standard working hours may be required based on operational needs.
• Controlled activities must be performed within approved procedures, completed training, and appropriate supervision.

We Are an Equal Opportunity Employer

OcyonBio provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws.

This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training.

If you are looking to contribute to a growing organization advancing next-generation therapies while building your career in a dynamic and collaborative environment, OcyonBio offers the opportunity to make a meaningful impact. Join us as we continue shaping the future of healthcare. To learn more about us, please visit our website: "https://ocyonbio.com"