Job Description

Primary Purposes of Position

The Process Engineer will provide technical and process engineering solutions to support, develop, and improve existing and new manufacturing processes

Main Duties to be Performed:

  1. Assess current plant and equipment capability and propose process engineering solutions for the manufacturing processes, in particular, the development of optimal mixing, evaporation, filtration, chromatography, drying and blending processes. Propose and implement solutions to continuously improve the manufacturing process from chemical handling, automation and process engineering points of view
  • Be the expert on manufacturing process equipment and instrumentation
  • Create P&IDs and process flow diagrams for manufacturing equipment and processes
  • Provide process engineering support to new capital projects
  • Identify and assess new and existing equipment for new process introduction
  • Assist in the resolution of Unplanned Events relating to process equipment to understand root cause for process events and propose effective CAPAs
  • Participate in risk assessments and HAZOPs of manufacturing processes and equipment
  • Perform validation of new equipment by preparing qualification/validation protocols and reports

Specifics of Position:

  • Have a thorough understanding of the theory behind the unit operations
  • Be flexible and capable of working on own initiative, without close supervision
  • Be committed to working to the highest possible standards and delivering high quality results within a highly regulated (cGMP and EHS) environment
  • Be able to plan effectively and work on multiple projects at the same time
  • Be familiar with requirements of cGMP and regulatory guidelines, especially as relates to equipment qualification, validation, and change control
  • Be able to work well within a team and possess excellent interpersonal and communication skills
  • Have good attention to detail and possess excellent documentation and data analysis skills
  • Be familiar with root cause analysis and problem solving techniques
  • Be familiar with identification of hazards and risk assessment

Education:

-Chemical Engineering Degree

Experience (Proficiency):

3+ years experience in pharmaceutical industry, familiarity with six sigma/continuous improvement methodologies, working in a API environment

 
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