Molding Process Engineer, Pharmaceutical Injection Molding
Overview
injection molding focused role leading process development and validation in a regulated pharmaceutical manufacturing environment at scale. You will partner with Manufacturing Quality Tooling Automation Validation and Regulatory teams to ensure compliant cost-effective processes. This onsite role emphasizes lifecycle process control continuous improvement and data-driven decision making. What sets this role apart is the opportunity to influence molding processes from development through qualification in a healthcare context.
What You'll Do10
- 1Build and qualify equipment mold and process qualifications including URS FAT SAT IQ OQ and PQ
- 2Design and defend material acceptability with technical reports change controls and issue reviews
- 3Provide process support to production facilities to maintain robust manufacturing performance
- 4Develop validated process windows using scientific molding principles
- 5Collaborate with Tooling and Maintenance on mold design reviews qualifications and preventive maintenance
- 6Monitor process performance downtime scrap yield and capability using manufacturing data systems
- 7Lead or support investigations into nonconformances deviations and audit findings
- 8Ensure compliance with good manufacturing practices and implement reliable testing techniques
- 9Lead materials- and process-related projects coordinating cross functional teams
- 10Review process data with tools like Minitab JMP Power BI Excel or equivalent
Requirements5
- 1Bachelor 0Degree in Plastics Engineering Manufacturing Engineering Industrial Engineering or related field
- 2Minimum 3 years of experience in injection molding process engineering validation or related regulated manufacturing environment
- 3Knowledge of Statistical Process Control and Design of Experiments
- 4Experience with molding processes tooling and mold design and manufacture
- 5Proficiency with manufacturing data systems MES ERP SPC software electronic documentation systems and data visualization tools
Salary Insight
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