Process Engineer
Katalyst CRO · Bloomington, IN · Yesterday
HybridContract
Roles & 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.
Requirements
- 35 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.
Mandatory Skills / Competencies
- GMP Compliance
- Process Validation
- Root Cause Analysis
- CAPA
- Data Analysis
- Cross-functional Collaboration
- Problem Solving