Process Engineer, Tissue Culture (Process Analytics)

Calling all upstream & tissue culture Process Engineers!  Our Regenerative Medicine client is a mid-size, clinical stage, public company with multiple hiring needs in their MSAT group across all levels (Engineer II, Engineer III, Senior, & Principal).
 
Located in Durham, NC, the company was founded by doctors & engineers to develop and manufacture acellular tissues for the treatment of diseases and conditions in multiple therapeutic areas. The company’s innovative technology supports tissue repair, reconstruction, and replacement across vascular markets including trauma, arteriovenous access, peripheral arterial disease, and coronary artery bypass. 
 
The main function of this role is to support the development and execution of process analytics, process support, and control strategy activities. 
 
Responsibilities include but are not limited to;
• Provide advanced level support for execution and development of the manufacturing control strategy and Process Analytics program.
• Acquire, analyze, and report data trends using graphical and statistical methods and make recommendations based on data analysis.
• Develop systems and processes for the acquisition and analysis of data trends from process, equipment, and raw materials.
• Apply statistical process control techniques to independently develop and implement  process specifications, parameters, operating ranges, and action limits following appropriate change controls.
• Support the execution of commercial manufacturing campaigns.
• Provide guidance to others on complex theory and concepts behind the process including an understanding of the impact of any process changes or improvements, as well as the impact of any process deviations or drift.
• Proactively identify technical issues on bioprocessing equipment, recommend corrective activities, and implement procedures to prevent reoccurrence.
• Author SOPs, reports, and protocols and solicit Manager approval for final documents.
 
Formal descriptions can be supplied for interested candidates.
 
Qualified candidates will have;
• BS or MS degree in chemical engineering, biochemical engineering, biotechnology, or other relevant discipline
• 2+ years of cGMP pharma or biotech industry experience in bioprocess, cell technology, biomedical engineering, cell therapy, tissue engineering, regenerative medicine, or process development. 
• Demonstrated experience with the Process Validation Lifecycle and Statistical Process Control methods
• Experience with application of analytical systems and computational methods to biological systems in a GMP environment
 
Priority given to those with;
• Technical foundation of cell- and tissue- based products.
• Experience with bioprocessing deviations, change control, and process optimization.
• Advanced knowledge of statistical process control methods and data interpretation.
• Knowledge of multivariate modeling techniques.
• Familiarity with data engineering concept for collection, storage, & validation of data.
• Ability to independently troubleshoot advanced or moderately complex bioprocess activities and perform typical and atypical bioprocess optimization studies.
• Advanced knowledge of the cell biological aspects of the process, as well as the Engineering and mass-transfer aspects.
 
Must be authorized to work in the US indefinitely to be considered and must be commutable to the Durham, North Carolina area or able to relocate with very limited assistance. 
 
All resumes will be kept strictly confidential until you choose to pursue a specific opportunity with one of our clients.