Process Development Engineering Specialist

Biospectra Inc-posted 3 months ago
Bangor, PA
251-500 employees
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BioSpectra is seeking a Process Development Engineer to execute projects in support of BioSpectra’s process development initiatives. These projects include development/validation of new products and processes, increasing capacity of current products, improving safety, compliance, cost of manufacturing and other areas of continuous improvement.

  • Executes process and product development projects as assigned by effectively planning, monitoring and taking action to resolve issues that arise in a timely manner.
  • Assists in the design of chemical manufacturing processes by providing input into the process design, process path and equipment selection to ensure the effectiveness of the process.
  • Evaluates manufacturing processes, development/manufacturing batch records and operational procedures and makes recommendations to leadership to improve increase throughput, reduce costs and improve safety.
  • Provides input into the design and selection of process equipment and troubleshoot process equipment and utilities as required.
  • Works closely with process validation to ensure that changes to process and equipment are properly handled within BioSpectra's change management procedures.
  • Trains manufacturing personnel in how to best operate manufacturing equipment to ensure manufactured product meets required specifications.
  • Ensures executed development plans are documented, reviewed and approved by appropriate personnel.
  • Works closely with EHS management to assess manufacturing processes and equipment with respect to safety and environmental impact and make recommendations as to changes needed.
  • Degree in chemical engineering or other related field and/or commensurate experience.
  • Five or more years’ experience in process engineering for a chemical, food, materials bio-pharmaceutical manufacturer.
  • Demonstrated effective working knowledge and ability managing projects, analyzing data, using statistical methods and engineering principles, with material/chemical processing equipment, and technical writing.
  • Ability to communicate effectively in writing and orally.
  • Ability to learn how to effectively develop batch procedures and manage process changes and validations per regulatory guidelines.
  • Ability to work effectively with Microsoft Word, Excel, and other applicable statistical and engineering software.
  • Demonstrated excellence in designing, and optimizing manufacturing processes, ideally with experience in driving continuous process improvements.
  • General working knowledge of SPC, DOE, Six Sigma, Lean and/or other process improvement methodology and systems.
  • Results-orientation with a proven ability to deliver tangible outcomes and measurable results.
  • Demonstrated technical and mechanical ability to diagnose, decide on a course of action and resolve manufacturing process issues.
  • Ability to write, orally communicate and effectively communicate technical information in a concise and understandable way.
  • Demonstrated ability to use software technology and systems, including statistical software to assist the organization in driving process performance excellence.
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