Senior Validation Engineer - 176691

Responsibilities: of the Senior Validation Engineer include: · Lead the development, execution, analysis, and reporting of Installation Verification (IV), Operational Verification (OV), and Performance Verification (PV) protocols for manufacturing equipment and processes. · Manage validation-related change controls, review protocol documentation, and ensure all activities meet regulatory and site quality standards. · Author and maintain validation plans, project quality documentation, procedures, specifications, and supporting records required to sustain a validated state. · Drive investigations associated with validation deviations, failures, and nonconformances using structured root cause analysis methodologies. · Support FAT, SAT, commissioning, and startup activities while coordinating validation project schedules, contractors, and cross-functional stakeholders. Qualifications: for the Senior Validation Engineer include: · Bachelor's degree in Engineering, Computer Science, or a related technical discipline; advanced degree preferred. · 7+ years of validation experience within pharmaceutical, biotechnology, medical device, or other highly regulated manufacturing environments. · Strong knowledge of GMP requirements, FDA regulations, 21 CFR Part 11, GAMP 5, ICH guidelines, and computerized system validation principles. · Demonstrated experience with automated manufacturing equipment validation, change management, and complex root cause investigations. · Proven project leadership skills with the ability to manage multiple initiatives, technical documentation, timelines, and cross-functional teams. Compensation: for the Senior Validation Engineer: Salary Range: $74-$84/hr (USD) Comprehensive Benefits: Medical, Dental, Vision, sick leave if required by law, and 401K This job opens for applications on 9/30/26. Applications for this job will be accepted for at least 30 days from the posting date.