Overview As a Process Engineer II in a pharmaceutical/biotech manufacturing setting, you will optimize production processes and drive improvements to ensure product quality and regulatory compliance. You will partner with Operations, Quality, Maintenance, and Engineering to enhance efficiency and reliability across manufacturing lines. You will lead validation activities, support technology transfer, and address deviations with CAPAs. This role offers impact through cross-functional collaboration, data-driven decisions, and continuous improvement initiatives that support scalable, compliant production.
Responsibilities- Support daily manufacturing operations and troubleshoot process issues
- Analyze production data to identify process improvement opportunities
- Develop and update manufacturing procedures and work instructions
- Lead process validation and equipment qualification activities
- Collaborate with Quality on deviation investigations and CAPAs
- Monitor KPIs and recommend corrective actions
- Support technology transfer and new product introductions
- Participate in risk assessments and continuous improvement initiatives
- Ensure compliance with GMP, FDA, and company policies
- Provide technical support to manufacturing personnel
Key requirements- 3-5 years of manufacturing or process engineering experience
- Experience in pharmaceutical, biotechnology, or medical device industries
- Knowledge of Lean Manufacturing principles
- Experience with process validation activities
- Bachelor's Degree in Chemical, Mechanical, Industrial, or Manufacturing Engineering
- cross-functional collaboration
- problem solving
- data analysis
- GMP Compliance
- Process Validation
- Root Cause Analysis
