Validation Engineer

Our client is a biotechnology/medical device company looking to add a Validation Engineer to their team in Ventura County, CA.

Salary/Hourly Rate:

$100k – $110k

Position Overview:

The Validation Engineer will lead validation activities for products, processes, and equipment across multiple sites. This role includes developing test methods, conducting risk assessments, and ensuring compliance with internal standards and regulatory requirements. The Validation Engineer role requires collaboration with cross-functional teams to support product verification and process optimization.

Responsibilities of the Validation Engineer:

• Define validation objectives and standards based on product and customer requirements.
• Develop and execute compliant validation protocols for products, equipment, and processes.
• Analyze validation data using statistical tools (DOE, capability analysis) to confirm compliance.
• Maintain technical documentation within design history files.
• Coordinate scheduling and implementation of validation activities.
• Investigate anomalies and failures during validation testing and recommend corrective actions.
• Track validation activities and results using appropriate systems.
• Prepare and review validation documentation, including schematics, protocols, and engineering change notices.
• Modify test methods and standards to resolve issues and optimize processes.
• Support product development teams with quality documentation, CAPA activities, and engineering change requests/orders.
• Collaborate with internal and external scientists and engineers to establish design and manufacturing specifications.
• Maintain accurate sample inventory and study tracking within laboratory systems.
• Perform additional duties as assigned.

Required Experience/Skills for the Validation Engineer:

• 2 – 5 years of experience in validation, quality assurance, or laboratory testing within a regulated industry.
• Preferred Experience/Skills for the Validation Engineer:
• Strong verbal and written communication skills.
• Familiarity with industry standards and regulatory guidelines (cGMP, FDA).
• Proficiency in statistical and scientific practices. Experience with DOE/SPC is preferred.
• Skilled in Microsoft Office Suite; experience with Minitab or similar statistical software is a plus.
• Coding experience (Python preferred) and benchtop electrical wiring knowledge are advantageous.

Education Requirements:

• Bachelor’s degree in Science, Engineering, Biology, or a related technical field is required.

Benefits:

• Medical, dental, and vision plans.
• Flexible Spending Accounts (FSA).
• Life and AD&D insurance.
• Disability coverage.
• Employee Assistance Program (EAP).
• 401(K) retirement plan.
• Additional wellness and referral programs.

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EOE/M/F/D/V/SO