Validation Specialist
KAPS Automation · Boston, MA · 4 mo ago
Quality AssuranceFull-time
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