Hybrid Senior Validation Engineer

at Avantor

• Job title: Senior Validation Engineer
• Job type: Full Time
• Experience level: Senior
• Salary: $77,300 - $128,700 per year
• Degree requirement: Bachelor's Degree
• Location requirements: Hybrid, Solon, United States

About the role

• Sr. Validation Engineer at Avantor providing equipment validation expertise in medical device and biopharma manufacturing. Overseeing installation and performance qualification with cross-functional collaboration.

Responsibilities

• Provide specialized knowledge in developing the strategy for equipment for processes
• Ensure proper installation, operational and performance qualification of equipment
• Prepare all protocols and reports for validation work
• Oversee and review validation area processes and procedures
• Author validation documents and execute validations of equipment
• Coordinate and lead validations to assure compliance with customer requirements and regulations

Requirements

• BS degree in Engineering or Life Science (Chemistry, Bio, Physics, etc.) preferred
• 5+ years of experience in Equipment, Cleaning, and/or Process Validation Engineering experience within a pharmaceutical or medical device company
• Knowledge of Industrial Quality Control, Quality Engineering, Quality Assurance and Validation
• Knowledge of CFRs and their application to Medical Devices
• Knowledge of software packages supporting statistical data analysis, word processing, flow charting, and project management
• Familiarity with manufacturing methods related to medical devices
• Strong communication skills, both verbal and written
• Ability to work independently and as a team member

Benefits

• Health insurance
• Dental coverage
• Vision coverage
• Wellness programs
• Health savings and flexible spending accounts
• 401(k) plan with company match
• Employee stock purchase program
• 11 paid holidays
• 18 PTO days annually
• Volunteer time off
• 6 weeks of paid parental leave