Process Development Engineer

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.