Principal Process Engineer

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.