Validation Associate
About The Position
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.
Requirements
- 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.
- 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 escalate 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.
Nice To Haves
- Academic, internship, or work exposure to pharmaceutical, biotechnology, medical-device, or other regulated manufacturing operations.
- Familiarity with validation or qualification concepts, GMP, GDP, technical writing, and risk-based practices.
- Basic exposure to manufacturing equipment, laboratory instruments, utilities, automation, or computerized systems.
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 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 escalate 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.
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
