Senior Validation Engineer

Responsibilities: of the Senior Validation Engineer: Provide validation and technical support through the preparation, execution, data analysis, and reporting of IQ/OQ/PQ (IV/OV/PV) protocols. Own Change Requests (CRs) related to validation activities and project deliverables. Author and review Validation Plans (VPLs), Project Quality Master Plans (PQMPs), protocols, reports, and associated validation documentation. Execute validation activities for direct-impact systems, equipment, and processes while ensuring project timelines are met. Perform compliance reviews and technical approvals of protocols, reports, and validation data. Lead validation investigations, deviations, and non-conformances using root cause analysis methodologies. Ensure validation activities comply with local, corporate, and regulatory requirements. Create and revise validation procedures, configuration item lists (CILs), specifications, and SOPs as needed. Support FAT, SAT, commissioning, qualification, and startup activities for equipment, automation systems, and manufacturing processes. Identify process improvements and support continuous improvement initiatives. Provide contractor oversight, project coordination, and budget support as required. Lead validation activities and serve as a subject matter expert for new systems and equipment implementations. Qualifications: of the Senior Validation Engineer: Bachelor's degree in Engineering, Computer Science, or a related technical discipline; equivalent experience will be considered. Master's degree preferred. 7+ years of validation, quality, or related experience within the pharmaceutical or medical device industry. Strong knowledge of GMP manufacturing environments and validation lifecycle activities. Experience with regulatory and industry standards including 21 CFR Part 11, GAMP5, ISO standards, FDA regulations, and ICH guidance. Proven experience leading investigations and applying root cause analysis techniques to resolve complex issues. Ability to author and review technical documentation, protocols, reports, and procedures. Demonstrated project leadership, communication, and cross-functional collaboration skills. Experience managing multiple priorities and delivering projects within established timelines. Strong understanding of change control processes and validation compliance requirements. Pharmaceutical manufacturing and fill/finish experience preferred.