Process Development Engineer

BioSpectra, Inc.

$80K — $95K *
Pharmaceuticals & Biotech
Less than 5 years of experience
Job Overview by Ladders

Qualifications

  • University degree in Chemical Engineering or equivalent experience
  • 3+ years in process engineering within relevant industries
  • Experience in cGMP manufacturing environments
  • Knowledge of fermentation and ultrafiltration processes
  • Familiarity with production planning and inventory management

Responsibilities

  • Design chemical manufacturing processes and select appropriate equipment
  • Implement compliance requirements for manufacturing processes
  • Evaluate processes to recommend improvements for cost and safety
  • Troubleshoot process equipment as needed
  • Document development plans and conduct thorough reviews
  • Train manufacturing personnel on equipment operation
  • Execute and monitor process and product development projects

Benefits

  • Professional development opportunities
  • Collaborative work environment
  • Involvement in innovative process improvement initiatives
  • Health and safety compliance focus
  • Opportunity to impact product quality and manufacturing capacity
Full Job Description
Dextran Products is seeking a Process Development Engineer to lead and execute engineering projects in support of Dextran Products' chemical manufacturing process and 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. Major Roles and Responsibilities: Process Engineering & Design • Designs chemical manufacturing processes establishing and documenting process path and equipment selection to ensure the effectiveness of the process. • Implements complex chemical manufacturing processing to meet the compliance requirements for associated products. • Implements Quality requirements according to IPEC Guidelines. Process Optimization • Evaluates manufacturing processes, development/manufacturing batch records and operational procedures • Makes recommendations to leadership to improve increase throughput, reduce costs and improve safety. Equipment Selection & Installation • Provides input into the design and selection of process equipment • Troubleshoots process equipment and utilities as required. Documentation • Ensures executed development plans are documented, reviewed and approved by appropriate personnel. • Documents work performed in batch records, validation protocols, logbooks, laboratory notebooks, etc. • Creates process flow diagrams, risk assessments, operating procedures. Change Management • Works closely with process validation to ensure that changes to process and equipment are properly handled within Dextran Products and change management procedures. Process Training • Trains manufacturing personnel in how to best operate manufacturing equipment to ensure manufactured products meet required specifications. Leadership • Guides manufacturing operators on the design and execution of process development projects and improvements. • Complete development goals as established with the Managing Director. • Assist in the Plant when it is needed. Maintain constant communication with manufacturing and quality personnel. Project Management • Executes process and product development projects as assigned by effectively planning and monitoring • Acts to design and develop processes and resolve issues that arise in a timely manner. • Communicates the status of these projects to members of management, as needed. • Report and maintain appropriate communications with the Managing Director. Environmental Health & Safety Assessment • 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. • Ensure that all waste generated in the course of assigned job tasks are handled in compliance with Company policy and procedures and local regulations Qualifications: Education • A University degree in Chemical Engineering or other related fields and/or approved equivalent experience. Experience • Three or more years' experience in process engineering for a chemical, food, materials, bio- pharmaceutical, winery or any related field. • In the pharmaceutical, yogurt, winemaking, food, flavor, fragrance industries or manufacturers using a yeast extraction process. • With production planning and managing inventory. • With a cGMP compliant manufacturer Skills and Abilities: The ideal candidate will have a combination of the following experiences: • Fermentation, Diafiltration, ultrafiltration, spray drying and production planning • 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. • Understand requirements of the Dextran quality system and direct department staff to ensure they are able to read, understand, interpret and perform all tasks and activities are in compliance. • Ability to work effectively with Microsoft Word, Excel, and other applicable statistical and engineering software.

Similar Jobs

More Jobs at BioSpectra, Inc.

More Pharmaceuticals & Biotech Jobs

Find similar Process Development Engineer jobs: