Sr Process Validation Engineer - Spark Life Solutions Inc
Billerica, MA 75074
About the Job
Roles & Responsibilities:
- Process Validation (IQ/OQ/PQ)
- Process Layout, Modeling, and Documentation
- Equipment and Tooling Development
- Process Development and Characterization
- Test Method Development and Validation
- Developing / Updating MPIs
- Supplier Development and Component Engineering
- Manufacturing Engineering Support / Engineering Documentation
- Update work instructions to match the practice on the floor to what's in the procedure.
- Create part numbers for some of the machine spare parts and supply items.
- Update the tooling / fixture drawings to reflect what is used in the production floor
- Bachelor's Degree in Engineering (e.g., Mechanical Engineering, Industrial Engineering, or a related field). A Master's degree is a plus.
- 5+ years of experience in manufacturing engineering, process development, or a related field within a regulated industry
- Hands-on experience in developing and optimizing manufacturing equipment and tooling.
- Experience in developing and validating test methods for manufacturing processes.
- Proficiency in updating work instructions, creating part numbers, and revising tooling/fixture drawings to reflect current production practices.
- Certifications: Lean Six Sigma Green Belt or equivalent certification preferred.
Source : Spark Life Solutions Inc
