Validation Engineer (pharma)

About the role

The Validation Engineer plans, coordinates, and executes qualification activities for facilities, utilities, and manufacturing and packaging equipment supporting the oral liquid plant. The role ensures qualification readiness, lifecycle compliance, and continued validated status in accordance with GMP, regulatory requirements, and company quality standards.

Key responsibilities

• Develop, execute, review, and maintain qualification protocols and reports covering Design Qualification, Installation Qualification, Operational Qualification, and Performance Qualification.
• Lead qualification activities for manufacturing and packaging equipment, production areas, facilities, and supporting utilities.
• Plan qualification deliverables, schedules, supporting resources, and execution activities in line with project and operational requirements.
• Lead qualification activities for HVAC systems, purified-water systems, compressed-air systems, production areas, and supporting utilities.
• Review User Requirement Specifications, design and engineering documents, commissioning records, Factory Acceptance Test documents, and Site Acceptance Test documents to confirm qualification readiness.
• Perform qualification risk assessments and identify critical systems and parameters that may affect product quality or patient safety.
• Investigate qualification-related deviations and coordinate timely resolution.
• Prepare, review, issue, and maintain validation and qualification documentation in compliance with GMP and document-control requirements.
• Coordinate qualification activities with Engineering, Production, Quality Control, Quality Assurance, Validation, project teams, and external vendors.
• Support regulatory inspections, customer audits, and quality assessments by providing qualification documentation and technical expertise.

Requirements

• Bachelor's Degree in Engineering, Pharmaceutical Science, or a related discipline.
• Experience in GMP pharmaceutical manufacturing, preferably within oral liquid manufacturing or a related dosage-form environment.
• Working knowledge of qualification lifecycle principles, including DQ, IQ, OQ, and PQ.
• Good understanding of GMP, Annex 15, PIC/S guidance, risk-based qualification, and validation principles.
• Experience preparing or reviewing qualification protocols, reports, engineering documents, FAT and SAT records, deviations, CAPA, and change-control assessments.
• Strong technical-writing, analytical, problem-solving, project-coordination, and documentation skills.
• Ability to work effectively with cross-functional project teams and external vendors.
• Systematic and detail-oriented approach to qualification execution and technical documentation.
• Strong ownership of timelines, follow-up actions, and document completion.
• Clear communicator who can coordinate technical activities across departments and vendors.