Process Engineer

Job Responsibilities

• Lead the specification, procurement, installation, and qualification of packaging equipment, including managing parts of the capital budget and providing regular project status updates.
• Monitor and analyze manufacturing data to support process improvement initiatives and investigations.
• Participate in and support process FMEAs to identify and assess process and product risks, laying the groundwork for successful process validation.
• Ensure smooth execution of process comparability and validation runs by evaluating risks, implementing preventative measures, and troubleshooting equipment and process challenges.
• Lead investigations using a structured DMAIC approach to identify root causes and assess impacts, ensuring uninterrupted manufacturing operations and driving process improvements.
• Author technical documentation, including protocols and reports for equipment qualifications, comparability, and manufacturing process validation; collaborate with vendors and suppliers to define requirements and understand functional specifications.

Qualifications

• Proficiency in data management tools and Reliability-Centered Maintenance (RCM).
• Bachelor's degree or higher in Chemical, Electrical, or Mechanical Engineering, Biochemistry, Bioengineering, or a related scientific field.
• At least 5 years of experience in the biopharmaceutical or another GxP-regulated industry.
• Experience working with CMOs or CDMOs.
• Technical certifications in Lean Six Sigma or related methodologies are a plus.