Process Engineer

3 weeks ago


Alabaster, Alabama, United States Croda Full time
Job Description

Job Title: Process Engineer

Job Summary:

We are seeking a highly skilled Process Engineer to join our team at Croda. As a Process Engineer, you will be responsible for performing and/or leading a wide array of manufacturing process/equipment development and engineering activities in a pharmaceutical cGMP environment.

Key Responsibilities:

  • Lead projects or participate on project teams to develop the manufacturing process for new products and implement improvements to existing manufacturing processes
  • Assist in the design and procurement of new equipment and lead commissioning, start-up, installation, or qualification activities including authoring IQ/OQ/PQ protocols, test execution, and authoring summary reports
  • Assess equipment changes (repairs, replacement, automation, improvements, etc.) for impact to validated processes and, if necessary, perform process qualification or re-validation
  • Design and execute studies as required to investigate, optimize, troubleshoot, and implement process improvements
  • Work on multiple process development and validation projects simultaneously and coordinate test work with various other departments
  • Write procedures, protocols, and technical reports for manufacturing, utility, performance qualifications, lab equipment, cleaning, and process validation
  • Compile validation packages and assure all required documentation is accurate and complete
  • Champion process improvement projects and ensure equipment and systems remain in a qualified state

Investigations:

  • Lead or assist in general investigations (from deviations, OOS Investigation, Batch Failures, customer complaints, etc.)
  • Lead or assist in equipment/process related risk assessment exercises for potential changes to equipment/processes, impact assessment for deviations to processes/equipment
  • Ensure thoroughness of investigation, including documentation and closure

Requirements:

  • BS degree in Chemical Engineering or related life science
  • Previous relevant work experience in a related field required
  • Experience providing technical support in a cGMP manufacturing environment including hands-on process development, optimization, and troubleshooting of equipment and processes is preferred
  • Experience with process equipment, filling or packaging equipment, cleaning validation planning and execution, piping and instrumentation diagrams (P&ID), chemical process engineering, and pharmaceutical process development is preferred

About Croda:

Croda recognizes employees as our strength and the diversity they bring to our workforce are directly linked to our ongoing success. We are an equal opportunity employer and place a high value on diversity and inclusion at our company.


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