Process Engineer 3 (Downstream Engineering – Chromatography) Position Available In Wake, North Carolina

Process Engineer 3 (Downstream Engineering – Chromatography)
Job Locations
US-NC-Holly Springs
Posted Date
6 days ago
(5/5/2025 6:51 PM)
Requisition

ID 2025-34487

Category Engineering Company (Portal Searching) Diosynth Biotechnologies
Position The Process Engineer 3 provides engineering guidance to support capital projects, technology transfer, and manufacturing operations. This will ensurepliance with all safety, regulatory, and engineering requirements. This role will ad to product and customer requirements, and work towards optimizing plant efficiency and profitability. Company Follow Your Genki to North America’s largest, state-of-the-art Life Science Manufacturing Facility & CDMO The work we do at Diosynth Biotechnologies has never been more important—and we are looking for talented candidates to join us. We are growing our locations, our capabilities, and our teams, and looking for passionate, mission-driven people like you who want to make a real difference in people’s lives. Join Diosynth Biotechnologies and help manufacture the next vaccine, cure, or gene therapy in partnership with some of the most innovative biopharmapanies across the globe. We are proud to cultivate a culture that will fuel your passion, energy and drive – what we call Genki. Join us We are growing our locations and are investing more than $2 billion into establishing a new large-scale manufacturing site for biopharmaceuticals in the United States to accelerate the growth of our Bio CDMO (Contract and Development Manufacturing Organization) business. This will be the largest end-to-end cell culture CDMO provider in North America. The new site will offer end-to-end solutions to our customers looking to manufacture biopharmaceuticals in the US. In addition to drug substance manufacture, it will also provide automated fill-finish and assembly, packaging, and labeling services. The new state-of-the-art facility is located in Holly Springs, North Carolina, United States. Job Description What You’ll Do

• Serves as point of contact to the Engineering, Procurement, Construction Management (EPC) provider
• Secures on time delivery and ensures quality from Fujifilm and EPCM provider for moderateplexity equipment packages
• Develops and aligns moderateplexity plans and provides mitigations, as needed
• Reviews piping and instrumentation diagram (P&IDs) and other process design documents
• Provides direction to detailed design activities in partnership with the EPCM provider
• Writes User Requirement Specifications (URSs)
• Supports Factory Acceptance Testing (FAT), Commissioning Qualification and Validation (CQV), and start-up activities
• Serves as on-call support for process equipment
• Reviews, redlines, and approves P&IDs and other technical documents as the technical authority
• Leads system impact assessments and quality risk assessments for process equipment
• Performs technology transfer (TT) activities related to process equipment
• Supports execution of Good Manufacturing Practices (GMP) runs
• Provides technical support for root cause analysis (RCA) and process deviation investigations
• Leads or assists with deviations, change controls, and corrective and preventive action (CAPA) closures
• Makes decisions regarding technical risk assessments for new manufacturing equipment
• Provides on-floor manufacturing support for equipment issues
• Provides process equipment training and consultation on topics within assigned area(s)
• Participates in identifying continuous improvement projects within unit operations, in partnership with Manufacturing when applicable, to improve manufacturability, reliability, yield and cost
• Supports supplier technical evaluations, risk assessments, and equipment evaluation and qualification
• Conducts training and presents information to team or other stakeholders
• Cross-trains on unit operations to assist team with achieving deliverables
• Collaborates with other departments, such as Quality, Manufacturing, Process Science, Maintenance, and Automation
• Other duties, as assigned Minimum Requirements
• Bachelor’s degree in Chemical or Biotechnology Engineering, or another related field with 5 years of Engineering or other relevant
  technical experience; or
• Master’s in Chemical or Biotechnology Engineering with 3 years of Engineering or other relevant technical experience
• Experience in Life Science or other regulated industry
• Experience with Engineering drawings and Quality Systems (e.g., deviation management, change control, CAPA, document
  management system) Preferred Requirements
• Prior experience working in a cGMP environment or other highly regulated industry
• Experience working in at least one unit operation in a pharmaceutical or Life Science environment
• Experience with mammalian cell culture processe Working & Physical Conditions Will work in environment which may necessitate respiratory protection May work in Mechanical/Production spaces that may require hearing protection and enrollment in a hearing conservation program.

Ability to discern audible cues. Ability to ascend or descend ladders, scaffolding, ramps, etc. Ability to stand for prolonged periods of time up to 120 minutes. Ability to sit for prolonged periods of time up to 240 minutes. Ability to conduct activities using repetitive motions that include wrists, hands or fingers. Ability to operate machinery and/or power tools. Ability to conduct work that includes moving objects up to 33 pounds. Ability to bend, push or pull, reach to retrieve materials from 18″ to 60″ in height, and using twisting motions. Will work in warm/cold environments (60-90 range). Will work in small and/or enclosed spaces. Will work in heights greater than 4 feet.