Process Development Engineering Specialist

Process Dev

BIOSPECTRA PROCESS DEVELOPMENT ENGINEERING SPECIALIST

If you like the idea of leveraging your engineering skills to become part of a growing chemical manufacturing company and a major supplier to the bio-pharmaceutical industry, this may be the job for you!

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.

Major Roles & Responsibilities:

The ideal candidate will be able to perform the following responsibilities.

• Project Management: Executes process and product development projects as assigned by effectively planning, monitoring and taking action to resolve issues that arise in a timely manner. Communicates the status of these projects to members of management, as needed.
• Process Engineering & Design: 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.
• Process Optimization: Evaluates manufacturing processes, development/manufacturing batch records and operational procedures and 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 and troubleshoot process equipment and utilities as required.
• Change Management: Works closely with process validation to ensure that changes to process and equipment are properly handled within BioSpectra's change management procedures.
• Training: Trains manufacturing personnel in how to best operate manufacturing equipment to ensure manufactured product meets required specifications
• 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.
• 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.

Qualifications:

The ideal candidate will have a 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.
• Must have demonstrated effective working knowledge and ability managing projects, analyzing data, using statistical methods and engineering principles, with material/chemical processing equipment, and technical writing.
• Must be able to communicate effectively in writing and orally.
• Must be able to learn how to effectively develop batch procedures and manage process changes and validations per regulatory guidelines.
• Must be able to work effectively with Microsoft Word, Excel, and other applicable statistical and engineering software.

In addition, the ideal candidate will have the following qualities which will be critical to their success in this role.

• Technical Expertise: Demonstrated excellence in designing, and optimizing manufacturing processes, ideally with experience in driving continuous process improvements, with a general working knowledge of SPC, DOE, Six Sigma, Lean and/or other process improvement methodology and systems.
• Achieves Results: Results-orientation with a proven ability to deliver tangible outcomes and measurable results.
• Problem-Solving & Decision-making: Demonstrated technical and mechanical ability to diagnose, decide on a course of action and resolve manufacturing process issues.
• Communication: Ability to write, orally communicate and effectively communicate technical information in a concise and understandable way.
• Software Technology: Demonstrated ability to use software technology and systems, including statistical software to assist the organization in driving process performance excellence.

If you believe you have the experience and the right stuff to be part of BioSpectra’s Process Development team, please reach out to us!