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Process Development Engineer

Company: TalentBurst, Inc.
Location: Lexington
Posted on: May 26, 2023

Job Description:

TITLE: Process Development Engineer
INDUSTRY: Pharmaceutical Manufacturing
LOCATION: Greater Lexington, KY, Market
MODEL: Permanent, Full-Time Position


The Process Development Engineer is responsible for performing and/or leading a wide-array of manufacturing process/equipment development and engineering activities in a pharmaceutical cGMP environment. These activities include designing and leading studies to support process development. Writing/executing/summarizing protocols for testing equipment, product and processes. Also assists in troubleshooting, equipment and facility design, and cleaning/process validation activities.

Essential Duties:

  • Lead projects or participate on project teams to develop the manufacturing process for new products and implement improvements to existing processes for the manufacture of nasal spray drug products
  • Engage with the Pharmaceutical Development Group in all stages of product/process development to facilitate successful transfer of activities to the commercial manufacturing environment
  • 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 work with various other departments
  • Participate in the development and implementation of procedural or automation improvement changes
  • Write procedures, protocols and reports for manufacturing and cleaning/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
  • Lead investigations and assure thoroughness of investigation, identification of root cause, documentation and closure
  • Participate in design reviews of plant expansions or process changes, and serve as a technical point of contact or user representative for contract services
  • Provide support to Manufacturing, Quality, Maintenance, and Validation for deviation investigations, change controls and CAPA's through participation on cross functional teams
  • Lead risk assessment exercises related to equipment and processes, including Failure Mode Effect Analysis (FMEA).
  • Train technicians on Production Batch Records.
  • Assist or conduct investigations to resolve deviations, including Root Cause Analysis (RCA).
  • Other duties as assigned


    • BS in Chemical Engineering or related life science
    • Minimum of 2-5 years of previous work experience in a related field.
    • Experience providing technical support in a cGMP manufacturing environment including hands-on product development, optimization and troubleshooting of equipment and processes is preferred
    • Excellent working knowledge of cGMPs and regulatory requirements is preferred
    • Good interpersonal skills and the ability to work well in a team environment
    • Self-starting with outstanding work ethic; must be able to perform in a fast paced multi-product environment
    • Ability to maintain focus on tasks until completion and think analytically to solve problems when appropriate.
    • Ability to apply statistics and process capability methodologies to evaluate processes and to implement and monitor improvements
    • Strong listening, writing, reading, and verbal communication skills

Keywords: TalentBurst, Inc., Lexington , Process Development Engineer, Engineering , Lexington, Kentucky

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