Process and Validation Engineer
About The Position
The Opportunity: Avantor is seeking a Process and Validation Engineer to optimize our Biopharma Production organization. The Process and Validation Engineer will be responsible for multiple phases of manufacturing processes and process improvement projects. This high demand role will Implement process improvements to meet quality standards, design and conduct feasibility studies, and solve problems. This is a full-time position based out of our Devens, MA location. What we’re looking for: Education : Bachelor's degree. Experience: 4+ years related experience. GMP and biopharma manufacturing process experience desired. Additional Qualifications: Experience conducting risk assessments (IE: PFMEA, FMEA, 5WHYs). Ability to assist in the development and execution of validation protocols for new and in-use equipment and processes. Familiarity with lean manufacturing practices and the Toyota Production System (TPS; TPMS) a plus. Experience with six sigma process improvement methods (Green Belt preferred) desired. Advanced software application skills (IE. Access / Visio / Minitab). Ability to interface with process owners and users to obtain feedback and to verify performance. Experience working in a regulated environment (FDA or ISO 9001 preferred). Project management experience a plus.
Requirements
- Bachelor's degree.
- 4+ years related experience.
- GMP and biopharma manufacturing process experience desired.
- Experience conducting risk assessments (IE: PFMEA, FMEA, 5WHYs).
- Ability to assist in the development and execution of validation protocols for new and in-use equipment and processes.
- Ability to interface with process owners and users to obtain feedback and to verify performance.
Nice To Haves
- Familiarity with lean manufacturing practices and the Toyota Production System (TPS; TPMS) a plus.
- Experience with six sigma process improvement methods (Green Belt preferred) desired.
- Advanced software application skills (IE. Access / Visio / Minitab).
- Experience working in a regulated environment (FDA or ISO 9001 preferred).
- Project management experience a plus.
Responsibilities
- Develop and execute validation of equipment and processes.
- Create required documentation and aide in team communication.
- Serve as a resource to site associates in the coordination of work within the scope of assigned projects.
- Be accountable for analyzing production and supporting other areas as needed while identifying problems, developing 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 and develop initial documents for new processes and systems.
- Troubleshoot equipment and hardware.
- Manage data through data collection, modeling, and analysis.
- Manage data through cost/benefit analysis, process mapping and/or problem analysis.
- Perform other duties as assigned.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Number of Employees
251-500 employees
