Validation Specialist

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Validation Specialist

Boston, MA

Full-time

Apply by June 30, 2023

Overview Lead validation activities for automated systems in regulated environments. Develop and execute validation protocols in compliance with industry standards.

Employment Type

Full-time

Location

Boston, MA

Department

Engineering

Responsibilities

• Develop and execute validation protocols for automated systems
• Ensure compliance with regulatory requirements (FDA, GMP, etc.)
• Lead risk assessments and manage validation documentation
• Collaborate with engineering and quality assurance teams
• Perform qualification testing of automation systems
• Support audit activities and regulatory inspections
• Maintain validation documentation systems
• Train personnel on validation procedures and requirements

Requirements

• Bachelor's degree in Engineering, Computer Science, or related field
• 5+ years experience in validation within regulated industries
• Knowledge of GMP, FDA, and other regulatory requirements
• Experience with test execution and documentation
• Strong attention to detail and documentation skills
• Understanding of automated manufacturing systems
• Excellent project management abilities
• Experience in pharmaceutical, biotech, or medical device industries preferred

Benefits Competitive salary based on experience

Comprehensive health, dental, and vision insurance

401(k) retirement plan with company match

Paid time off and paid holidays

Professional development opportunities

Flexible work arrangements

Team building events and company outings

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KAPS Automation specializes in industrial automation solutions for various sectors including manufacturing, pharmaceutical, and energy.

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