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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
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