Validation Engineer

Responsibilities

• Plan, execute, and document Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) for new and existing equipment, including isolators, cleanroom HVAC systems, bio-safety cabinets, laminar flow hoods, pooling and filling equipment, and environmental monitoring systems.
• Validate and maintain the qualified state of facility utilities such as compressed air, clean steam, water for injection (WFI), HVAC, and differential pressure systems to support aseptic manufacturing.
• Support cleanroom qualification activities, including ISO classification, airflow visualization studies, and recovery testing, to ensure controlled environmental conditions.
• Write, execute, and review validation protocols, reports, and change controls, including those provided by third parties, in accordance with FDA 503B guidance, cGMP, and Annex 1 requirements.
• Maintain validation master plans (VMP), equipment qualification files, and complete lifecycle documentation to demonstrate ongoing control of systems and equipment.
• Ensure all validation activities meet data integrity expectations, including adherence to ALCOA+ principles for accurate, complete, and reliable records.
• Provide validation and qualification support to Quality and Operations teams to ensure equipment and facility conditions consistently support aseptic processing.
• Support aseptic processing studies such as media fills, smoke studies, and contamination control strategy implementation to maintain sterility assurance.
• Participate in investigations related to equipment failures, environmental excursions, or sterility assurance risks, and contribute to root cause analysis and corrective actions.
• Oversee calibration and preventive maintenance schedules for critical equipment to ensure reliable performance and regulatory compliance.
• Ensure vendors and service providers follow GMP standards and provide complete, compliant calibration certificates, preventive maintenance records, and service reports.
• Review and approve calibration certificates, preventive maintenance records, and service reports to verify accuracy and completeness.
• Evaluate equipment and facility changes for potential validation impact and define appropriate qualification or requalification activities.
• Perform risk assessments, including Failure Modes and Effects Analysis (FMEA) and hazard analyses, to support change control decisions and prioritize mitigation actions.
• Ensure requalification activities are completed following equipment modifications, repairs, or deviations to maintain validated status.
• Maintain validation documentation in an audit-ready state to support internal audits and regulatory inspections.
• Support internal audits and FDA inspections by presenting validation evidence, explaining validation strategies, and responding to technical questions.
• Identify gaps in validation and compliance systems and drive continuous improvement initiatives to enhance robustness, efficiency, and regulatory alignment.
• Collaborate cross-functionally with Quality Assurance, Operations, Facilities, and Engineering to align validation activities with production needs and regulatory expectations.

Qualifications

• Proven experience planning, executing, and documenting IQ/OQ/PQ for equipment such as isolators, cleanroom HVAC, bio-safety cabinets, laminar flow hoods, and sterile filling equipment.
• Hands-on experience with equipment qualification, cleanroom validation, and aseptic processing support in a regulated pharmaceutical environment.
• Experience overseeing equipment calibration programs and preventive maintenance schedules for critical systems.
• Strong understanding of cGMP requirements and practical experience applying them in aseptic pharmaceutical manufacturing.
• Experience supporting or conducting media fills, smoke studies, and contamination control strategy activities.
• Experience with risk assessment methodologies such as FMEA and hazard analysis in support of change control.
• Investigator training and experience writing clear, structured investigation reports.
• Experience reviewing batch records, manufacturing documentation, or Quality Assurance compliance records.
• Knowledge of data integrity principles and ALCOA+ expectations for validation and quality documentation.
• Excellent technical writing skills with the ability to produce clear, compliant validation protocols, reports, and lifecycle documentation.
• Strong problem-solving skills and the ability to analyze complex technical issues and propose practical, compliant solutions.
• Able to work effectively in a fast-paced, highly regulated environment and collaborate across multiple functions.
• 3–5 years of Quality Assurance or related experience in aseptic pharmaceutical manufacturing.
• 1 to 5 years of experience in aseptic pharmaceutical manufacturing, preferably in a 503B outsourcing or sterile injectable environment.
• Bachelor’s degree in Engineering, Life Sciences, or a related technical field.