Validation Engineer

Responsibilities: of the Validation Engineer include: • Lead commissioning, qualification, and validation activities for facility systems, manufacturing equipment, and supporting utilities within GMP-regulated operations. • Develop, execute, and review validation documentation including IQ/OQ/PQ protocols, validation plans, risk assessments, and final summary reports. • Support validation efforts across aseptic formulation and filling, device assembly and packaging, warehouse operations, QC laboratories, and computerized systems. • Partner with engineering, quality assurance, manufacturing, IT, and operations teams to ensure validation deliverables meet project timelines and regulatory expectations. • Investigate protocol deviations, implement corrective actions, and maintain compliance with FDA, EU GMP, and industry validation standards. Requirements of the Validation Engineer include: • 5+ years of validation experience within pharmaceutical, biotechnology, medical device, or other regulated manufacturing environments. • Hands-on experience supporting commissioning, qualification, and validation (CQV) projects for facility systems, manufacturing processes, or computerized systems. • Knowledge of aseptic processing, filling operations, packaging systems, warehouse validation, and/or QC laboratory validation. • Familiarity with cGMP regulations, FDA guidance, GAMP 5, and data integrity requirements. • Bachelor's degree in Engineering, Life Sciences, Computer Science, or a related technical discipline. Compensation: for the Validation Engineer include: • $130,000 - $160,000 annually • Full Comprehensive Benefits: Health, Vision, Dental, PTO, Paid Holiday and Sick Leave if Required by Law. • 2-year contract engagement with potential extension opportunities. • This job opens for applications on 10/02/2026. Applications for this job will be accepted for at least 30 days from the posting date.