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.
