Senior Process Engineer

Responsibilities

• Monitor and analyze manufacturing data to support process improvements and investigations.

• 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, including formulation, aseptic filling, inspection, and packaging.

• Proficient in data management tools and reliability-centered maintenance (RCM).

• Bachelor’s degree or higher in engineering, bioengineering, or a related scientific discipline.

• 7+ years of experience in biopharmaceutical or other GxP-regulated industries.

• Strong understanding of GMP manufacturing environments and validation processes.