MSAT/Process Engineer II

The MSAT Engineer - Analytics will support the development and execution of process analytics, process support, and control strategy activities with limited supervision and guidance. This role will be ~50% process analytics and 50% process engineering support. This role will collaborate effectively with personnel in Manufacturing, Engineering, Process Development, Quality Assurance, and Quality Control utilizing strong communication, and technical expertise to maintain and improve manufacturing operations.

Remote Work Designation: Not Remote

Major Accountabilities:

• Provides advanced level support for execution and development of the manufacturing control strategy and Process Analytics program 
• Acquires, analyses, and reports data trends using graphical and statistical methods and utilizes expertise to make recommendations to next level management based on data analysis
• Develops systems and processes for the acquisition and analysis of data trends from process, equipment, and raw materials.
• Applies statistical process control techniques to independently develop and implement (following appropriate change control) process specifications, parameters, operating ranges, and action limits. 
• Supports the execution of commercial manufacturing campaigns
• Provides guidance to others on advanced and/or moderately 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 identifies technical issues on bioprocessing equipment and recommends activities to resolve the issue. Implements procedures and activities to prevent the same issue from occurring.
• Authors standard operating procedures, reports, and protocols and solicit next level manager approval for final documents

 Special Competencies:

• Advanced knowledge of statistical process control methods and data interpretation
• Knowledge of multivariate modeling techniques
• Familiarity with data engineering concept for collection, storage, and validation of data
• Demonstrated technical foundation of cell- and tissue- based products and a strong familiarity with GMP manufacturing  
• Able to independently troubleshoot advanced or moderately complex bioprocess activities and perform typical and atypical bioprocess optimization studies 
• Possesses advanced knowledge of the cell biological aspects of the process, as well as the engineering and mass-transfer aspects of the process 
• Possesses understanding and demonstrated knowledge of equipment and procedures and identifies potential problem before they occur  

 General Competencies:

• Able to communicate effectively in English, both verbally and in writing
• Possess a positive roll-up-the-sleeves attitude and optimistic outlook
• Strong ability to work in a fast-paced team environment with fluctuating priorities, and collaborate effectively with others 
• Excellent organizational and time management skills with ability to set own priorities in a timely manner
• High degree of flexibility and adaptability 
• Basic computer skills required, such as knowledge of MS Word, Excel, PowerPoint, and Outlook 
• Must be able to work as needed to meet tight deadlines and at peak periods
• Self-motivated and organized critical thinker with solid interpersonal and business communication skills
• Demonstrated ability to work in a cross functional team
• Adheres to company and facility specific policies and procedures, including SOP, training and meeting requirements
• Always observe safety precautions and regulations in all areas where duties are performed
• Responsible for reporting all safety hazards and potential unsafe working conditions
• Ensures Humacyte or other required trainings/certifications are up to date
• Represents the organization in a positive and professional manner
• Reports to work on time and as scheduled

  Qualifications:

• BS in Engineering or other relevant discipline required.
• MS in related discipline preferred. 
• Background in chemical engineering, biochemical engineering, biotechnology, bioprocess, cell therapy, tissue engineering, regenerative medicine, or process development required.
• Minimum of 2 years of commercial manufacturing or Phase 3 CDMO or 6 years Phase 1-3 clinical manufacturing experience required.
• 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
• Demonstrated experience leading basic troubleshooting and participating in complex troubleshooting/
• Possess a demonstrated technical foundation of cell- and tissue- based products.
• Experience with bioprocessing deviations, change control, process optimization, and technical troubleshooting.
• Works well in a team environment.
• Strong experience working cross functionally within a BioPharma Bioprocessing organization.