Gene Therapy Senior Process Engineer

Sanford, North Carolina, United States
Oct 07, 2020
Required Education
Bachelors Degree
Position Type
Full time

The Senior Manufacturing Process Engineer, Downstream serves as an operations and technical expert supporting gene therapy drug substance purification. The incumbent should possess expertise in multiple areas that include:

Downstream / Purification
  • DeltaV / Unicorn
  • Single Use Technology
  • Column chromatography and experience leading column packing activities
  • Ultrafiltration / Diafiltration
  • Virus clearance

The incumbent is expected to have both substantive experience and knowledge that can be used to troubleshoot and solve problems on the floor independently. The incumbent will partner with the operations manager and operations specialists to ensure the area is in continuous state of audit readiness and should have experience in handling regulatory inspections. The incumbent is expected to have excellent written and oral communication skills.

The Senior Manufacturing Process Engineer will develop operators by sharing knowledge of operations and process design and coaching on ways to reduce waste and variability. In addition, the Senior Manufacturing Process Engineer will have responsibility for identifying areas of high risk and proactively implementing improvements, interfacing with site engineering, maintenance/calibrations, and technical operations to implement facility and process improvements, leading complex process-related investigations, implementing CAPA, and managing overall change in the area.

The incumbent must be able to work independently with limited direction, role model leadership behaviors, ability to influence across multiple functional groups and/or levels of the organization and be capable of representing the Operations Manager in cross-functional forums.

The incumbent is expected to maintain GMP documentation and documenting the manufacture of clinical ad commercial material. The incumbent must comply with applicable safety, occupational health, loss prevention and environmental requirements.


Troubleshoot and solve operational, automation, and process-related problems. Champion and implement improvements to business and GMP manufacturing processes that improve flexibility, eliminate waste, and reduce variability and risk. Develop operators' knowledge and skillset in GMP operations and process engineering concepts. Identify areas of high risk for equipment failure and human performance errors and proactively implement improvements. Independently interface closely with external vendors driving operational needs and resolution. Interface with site engineering and technical operations to implement facility and process improvements. Leading complex process-related investigations, implementing CAPA, and managing overall change in the area. Ability to author and execute studies and protocols for downstream operations. Maintain inspection readiness of area. Role model leader behaviors. Partner with EHS to build processes, tools, and mindsets that ensure a zero-injury workplace.


A minimum of a BS degree 5- 8 years of experience; MS 3-5 years of experience in any of the following disciplines: Chemistry, Biochemistry, Biotechnology, Chemical Engineering, Chemistry, Microbiology or equivalent science related or engineering discipline.
  • Last Date to Apply for Job: 10/19/2020
  • Eligible for Relocation Package
  • Eligible for Employee Referral Bonus
  • #LI-PFE

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