Validation Engineer

Job Title: Validation Engineer Location: Lafayette, CO

Experience: 3+ years

Overview We are seeking a skilled Validation Engineer to support validation activities across manufacturing processes, test systems, and equipment. This role is critical to ensuring compliance with FDA regulations, ISO standards, and internal quality systems. You’ll collaborate closely with cross-functional teams including Engineering, Quality, and Production to drive validation projects from planning through execution.

Key Responsibilities

Author, execute, and review equipment, process, and test method validation protocols (IQ/OQ/PQ)

Ensure validation activities meet FDA, ISO 13485, and internal quality system standards

Support integration of new equipment, process modifications, and continuous improvement projects

Work with Quality, Manufacturing, and R&D teams to define validation requirements

Perform risk assessments (FMEA), contribute to root cause analysis, and support CAPA implementation

Prepare and maintain complete validation documentation, including traceability and change control records

Act as subject matter expert during audits and regulatory inspections

Qualifications

• Bachelor’s degree in Engineering, Life Sciences, or a related technical field

• Minimum 3 years of hands-on validation experience in a regulated environment (medical device preferred)

• Proficiency in developing and executing IQ/OQ/PQ protocols and reports

• Strong knowledge of GMP, QSR, ISO 13485, and related regulatory standards

• Familiarity with validation tools and systems such as TrackWise or Minitab (preferred)

• Excellent technical writing, organizational, and communication skills