Process and Validation Engineer

1w1 week ago

Avantor

US · Full-time · $78,000 – $125,350

About this role

Avantor is seeking a Process and Validation Engineer to optimize our Biopharma Production organization. This role involves multiple phases of manufacturing processes and process improvement projects. Implement process improvements to meet quality standards, design and conduct feasibility studies, and solve problems.

The Process and Validation Engineer will develop and execute validation of equipment and processes. Create required documentation and aid in team communication. Serve as a resource to site associates in coordinating work within assigned projects.

Work in a production/clean room environment with adequate lighting, ventilation, and normal temperature and noise levels. Interface with process owners and users to obtain feedback and verify performance. Occasionally travel to other Avantor locations or customer sites.

Be accountable for analyzing production, identifying problems, developing countermeasures, and implementation. Manage optimization of resources and processes in compliance with company policies. Join a global team of 14,000+ associates advancing life-changing science and new patient treatments.

Requirements

Bachelor's degree
4+ years related experience
GMP and biopharma manufacturing process experience desired
Experience conducting risk assessments (PFMEA, FMEA, 5WHYs)
Ability to assist in the development and execution of validation protocols for new and in-use equipment and processes
Experience with six sigma process improvement methods (Green Belt preferred) desired
Advanced software application skills (Access / Visio / Minitab)
Experience working in a regulated environment (FDA or ISO 9001 preferred)

Responsibilities

Develop and execute validation of equipment and processes
Create required documentation and aid in team communication
Serve as a resource to site associates in the coordination of work within assigned projects
Analyze production and identify problems, develop countermeasures and implementation
Manage the optimization of resources and processes in compliance with company policies/procedures
Write SOPs and training documents to establish standard work
Troubleshoot equipment and hardware
Manage data through data collection, modeling, analysis, cost/benefit analysis, process mapping and problem analysis

Benefits

Join global team of 14,000+ associates whose passion for discovery advances life-changing science
Work that changes people's lives for the better
Bring new patient treatments and therapies to market
Equal opportunity employer