Job Description
Validation Engineer Job Summary The Validation Engineer is responsible for planning, executing, and documenting validation activities to ensure that products, processes, equipment, and systems meet regulatory, quality, and customer requirements. This role plays a critical part in maintaining compliance with industry standards and ensuring product reliability and safety. Key Responsibilities Lead validation activities including IQ, OQ, PQ, and CSV (where applicable) Develop and approve validation plans, protocols, reports, and traceability matrices Ensure compliance with applicable regulations and standards (e.g., FDA, ISO, GxP, ICH, IEC) Perform risk assessments (FMEA, risk-based validation approaches) Support new product introductions, process changes, and equipment qualifications Review and approve change controls, deviations, CAPAs, and SOPs related to validation Provide technical guidance and mentorship to junior validation engineers Collaborate with cross-functional teams to resolve validation and compliance issues Participate in audits and inspections (internal, customer, and regulatory) Drive continuous improvement in validation processes and documentation practices Required Qualifications Bachelors degree in Engineering, Life Sciences, or a related technical field 510+ years of validation experience in a regulated industry Strong knowledge of validation principles and lifecycle methodologies Hands-on experience with IQ/OQ/PQ execution and documentation Familiarity with quality systems and regulatory requirements Experience with risk management tools and change management processes Strong technical writing and documentation skills Ability to work independently and lead complex validation projects Preferred Qualifications Masters degree in Engineering or related field Experience with computer system validation (CSV) and data integrity Industry experience in medical devices, pharmaceuticals, biotech, or manufacturing Experience supporting regulatory inspections or customer audits Six Sigma, Lean, or quality certifications (a plus) Key Skills Validation strategy and execution Regulatory compliance Risk-based decision making Cross-functional collaboration Technical leadership and mentoring Problem solving and root cause analysis Attention to detail and documentation accuracy