Validation Engineer

Responsibilities

• Prepare and carry out commissioning and qualification deliverables including IQ, OQ, and PQ protocols and final reports
• Partner with cross-functional teams such as Quality, Engineering, Automation, and Manufacturing to coordinate validation execution activities
• Lead risk assessments, system impact evaluations, and apply risk-based validation methodologies
• Investigate and resolve deviations, non-conformances, and implement CAPA actions tied to qualification efforts
• Support startup activities including process validation, sterilization cycles, media fills, and facility readiness initiatives

Qualifications

• Bachelor’s degree in Engineering, Life Sciences, or another relevant technical field
• Minimum of 3 years of experience performing CQV or validation work within pharma, biotech, or sterile manufacturing settings
• Hands-on exposure to qualifying GMP systems such as sterilization equipment, inspection systems, or aseptic processing equipment
• Experience developing and executing IQ/OQ/PQ documentation along with strong technical writing capabilities
• Solid understanding of FDA GMP regulations, EU Annex 1, and industry validation practices

Pay

Salary Range: $155,000-$175,000/year (USD)

Benefits

• Medical
• Dental
• Vision
• sick leave if required by law
• 401K