MSAT Process Engineer, Tissue Culture (Equipment & SUB)

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 serve as primary responsible person to ensure bioprocessing equipment is ready for use when required.
 
Responsibilities include but are not limited to;
• Assist in equipment selection and design, qualification, and start up activities.
• Work with Bioprocessing to ensure robust procedures are utilized for operation of equipment.
• Lead efforts in troubleshooting out-of-trend manufacturing processes and providing leadership to identify and implement corrective actions.
• Provide guidance and is accountable for determining the root causes of equipment related deviations.
• Proactively identify technical issues on bioprocessing equipment, recommends corrective activities, and implements procedures to prevent reoccurrence.
• Designs and develops continuous improvement activities for process robustness and equipment functionality.
• Lead successful process transfers by partnering with Process Development.
• Provides comprehensive training and guidance to operations staff. 
• Working with Validation team to develop and execute validation strategies.
• Develops and execute test protocols, vendor site visits, FAT/SAT, etc.
 
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
• 5 – 10+ years of cGMP pharma or biotech industry experience in bioprocess, cell technology, biomedical engineering, cell therapy, tissue engineering, regenerative medicine, or process development. 
• Proficiency in a Process Engineering role with a clear understanding of cGMP manufacturing and experience leading projects related to bioprocessing deviations, change control, process optimization, technical troubleshooting, and bioprocessing process changes.
• Experience supporting and troubleshooting single use bioprocessing (SUB) technologies as well as fixed stainless steel bioprocessing equipment
 
Priority given to those with;
• Technical foundation of cell- and tissue- based products
• Experience performing and supporting cell culture based bioprocessing activities using adherent mammalian cells. 
• Strong operating knowledge of feedback control and monitoring of relevant process gasses, nutrients, biological waste products in mammalian cell systems welcome.
 
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.