Process Engineer: Engineering

Your work at Wildtype

• As a Process Engineer you will be responsible for working with Process Development and RD&I to understand process needs, identify equipment options to meet the needs, and manage the equipment implementation from bidding through final release for GMP use
• Lead cleaning development and sterilization validation for new equipment or for modifications existing cleaning procedures as needed for new products/new processes
• Develop SIP and CIP procedures for GMP process equipment 
• Assist in process automation development, including SIP and CIP 
• Assist in the development of bench scale CIP testing 
• Assist with the development of project execution plans
• Assist with the development and keeping project management tools up to date (e.g. equipment lists, working project folders, project schedules, meeting minutes, change management)
• Assist with development and review of MBRs, SOPs, and Best Engineering Practices (BEPs) 
• Provide input as an SME for process/facility/equipment changes
• Provide input as an SME for deviation investigations, identification/implementation of CAPAs
• Participate in future production facility design and implementation
• Author, as well as review, GMP documentation required and collaborate with Quality, Operation, Engineering & Scaling teams to implement procedures at manufacturing scale 

What we’ll teach you

• How to apply your expertise in upstream process development within the context of next-generation sustainable seafood production
• How to work with a fast-moving, interdisciplinary team working at the leading edge of numerous highly technical fields

What you bring to Wildtype

• BS in chemical engineering, chemistry or life sciences, with 5+ years of experience in upstream process development and/or manufacturing sciences technical support in biopharmaceutical, or industrial fermentation.
• A strong knowledge of general engineering principle & system setup.
• Experience with statistics in the areas of statistical process control and modeling is a strong plus.
• Understanding of various bioreactor control systems to design control strategies is a plus.
• A deep level of understanding and experience in developing CIP/SIP Circuitry, process equipment design reviews for CIP and SIP applications
• Experience & understanding of process scale-up/scale-down in a commercial setting & hands-on working knowledge on unit operations such as fermentation, centrifugation, CIP  & SIP is required.
• Must have a knowledge of quality systems concepts, such as, GMP guidelines, Deviation, change control, process and equipment validation, SOP and Batch records.

 Impact Plan

• Within 1 month you will
• Gain familiarity with our current process , ongoing development, and engineering/quality program documents
• Participate in weekly team meetings to coordination cross functionally with other departments
• Begin to perform CIP and SIP development and validation for upstream equipment
• Within 3 months you will:
• Be leading CIP/SIP process implementation
• Collaborating with the capital projects team to design future commercial production facility design
• Have progressed in implementation of the small scale CIP development program
• Work with PD & RD&I to understand their development of scaling strategies for production of Wildtype's seafood cell lines.
• Within 6 months & beyond  you will:
• Manage changes to CIP and SIP to support continuous improvement projects
• Have taken on responsibility for certain process equipment/processes to be implemented in the commercial production facility.
• Begin working as a contributor on a validation master plan 
• Perform review of process descriptions for scaled up processes (up to 10kL bioreactors)