Senior Process Development Engineering Specia

Biospectra Inc•Bangor, PA

About The Position

If you like the idea of leveraging your chemical engineering and project management skills and becoming part of a growing chemical manufacturer and a major supplier of chemical ingredients to the bio-pharmaceutical industry, this may be the job for you! BioSpectra is seeking a Senior Process Development Engineer to lead and execute engineering projects in support of BioSpectra’s 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. This is a career opportunity for someone who has the right skills and the drive to make a meaningful impact with a growing company!

Requirements

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.

Nice To Haves

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.

Responsibilities

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.
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.
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.
Works closely with process validation to ensure that changes to process and equipment are properly handled within BioSpectra's change management procedures.
Trains engineering and manufacturing personnel in how to best operate manufacturing equipment to ensure manufactured products meets required specifications.
Guides process engineers and manufacturing operators on the design and execution of process development projects and improvements.
Executes process and product development projects as assigned by effectively planning, monitoring and taking action 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.
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.