Validation Analyst

Summary

Join Encora as a Validation Analyst in a fully remote role supporting EST work hours for a 6+ month project. Develop and execute validation protocols (IQ, OQ, PQ) for equipment, systems, or processes. Perform risk assessments and define validation strategies. Document validation activities according to regulatory standards (e.g., FDA, EMA, GxP, 21 CFR Part 11). Collaborate with cross-functional teams. Support audits and inspections. Maintain validation lifecycle documentation. Track and manage validation deliverables and timelines. Stay updated on industry best practices and regulatory changes.

Requirements

• Bachelor’s degree in Life Sciences, Engineering, Computer Science, or related field
• Experience in validation (equipment, process, software, or computer systems)
• Familiarity with regulatory guidelines (GxP, 21 CFR Part 11, Annex 11, etc.)
• Strong analytical, documentation, and problem-solving skills
• Attention to detail and ability to manage multiple validation projects
• Excellent communication and organizational skills

Responsibilities

• Develop and execute validation protocols (IQ, OQ, PQ) for equipment, systems, or processes
• Perform risk assessments and define validation strategies based on system impact
• Document validation activities in accordance with regulatory standards (e.g., FDA, EMA, GxP, 21 CFR Part 11)
• Collaborate with cross-functional teams (QA, IT, Manufacturing, Engineering) to gather requirements and ensure validation readiness
• Support audits and inspections by providing validation documentation and responses
• Maintain validation lifecycle documentation including validation plans, reports, deviations, and change controls
• Track and manage validation deliverables and timelines for projects
• Stay current with industry best practices and regulatory changes

Preferred Qualifications

• Experience with computerized system validation (CSV)
• Knowledge of validation in regulated environments (e.g., pharmaceutical, biotech, medical devices)
• Proficiency in validation tools and documentation software
• Relevant certifications (e.g., ISPE, ASQ, or CSV certifications)