Senior Validation Engineer - 173960 - 174861

Responsibilities

• 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

• 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.
• Demonstrated ability to author and review technical documentation, protocols, reports, and procedures.
• Proven 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.