Senior Process Engineer

Responsibilities:

• Lead the specification, procurement, installation, and qualification of packaging equipment, overseeing relevant portions of the capital budget and providing regular project updates.
• Monitor and analyze manufacturing data to support process improvements and investigations as needed.
• Contribute to and assist with process FMEAs to assess process and product risks, ensuring readiness for process validation.
• Ensure successful comparability and process validation runs by evaluating risks, implementing preventive measures, and troubleshooting equipment and process issues.
• Drive and ensure the use of a systematic DMAIC approach for investigations related to processes and products, identifying root causes, assessing impacts, and maintaining smooth manufacturing operations while suggesting process improvements.
• Prepare technical documentation, including protocols and reports for equipment/instrument qualifications, comparability studies, and process and manufacturing validation testing. Collaborate with vendors and suppliers to define requirements and understand functional specifications.

Qualifications:

• Proficiency with data management tools and RCM.
• Bachelor’s degree or higher in chemical, electrical, or mechanical engineering, biochemistry, bioengineering, or a related scientific field.
• 5+ years of experience in the biopharmaceutical industry or another GxP-regulated environment.
• Experience with CMO/CDMO operations.
• Technical and/or Lean Six Sigma certifications.