What are the responsibilities and job description for the Principal Process Engineer position at Harba Solutions Inc.?
Responsibilities
- Monitor and analyze manufacturing data to support process improvements and investigations of aseptic filling processes.
- Participate in and support process FMEAs to assess risks and prepare for validation.
- Mentor and train team members.
- Lead process validation and comparability efforts by assessing risks, implementing preventive measures, and troubleshooting equipment and process issues.
- Drive root cause investigations using DMAIC methodology and identify improvements to support manufacturing operations.
- Collaborate with cross-functional teams to advance production activities.
- Evaluate and support implementation of new technologies and automation into GMP manufacturing.
- Author technical documents, including protocols and reports for equipment qualifications and process validation.
- Execute engineering studies, recipe development, and validation test cases.
- Coordinate with vendors and suppliers to define requirements and clarify functional specifications.
- Adapt to changing manufacturing needs and maintain flexibility in work schedule to support production operations.
Qualifications
- Experience with sterile injectables, specifically within aseptic filling.
- Proficient in data management tools and reliability-centered maintenance (RCM).
- Bachelor’s degree or higher in engineering, bioengineering, or a related scientific discipline.
- 8 years of experience in biopharmaceutical or other GxP-regulated industries.
- Strong understanding of GMP manufacturing environments and validation processes.
Salary : $130,000 - $160,000
