Senior Downstream Process Engineer - GMP Startup

ZP Group; Cary (NC); On-site; USD 175,000 - 190,000; Full time

Job summary

ZP Group is seeking a Downstream Process Engineer to lead the startup and commissioning of a new commercial-scale biopharmaceutical facility. You will oversee downstream purification startup, qualification, technology transfer, and ensure operational excellence, partnering with Manufacturing, MSAT, Validation, Quality, and Engineering teams.

The role requires a Bachelor's degree in a related field and 7+ years of GMP bioprocessing experience, with strong troubleshooting and cross-functional

Qualifications

• Bachelor's degree in Chemical Engineering, Biochemical Engineering, Biotechnology, or related field.
• 7+ years of downstream bioprocessing experience in a GMP manufacturing environment.
• Experience with commercial-scale chromatography, filtration, and purification processes.
• Experience supporting facility startup, commissioning, qualification, or process validation activities is highly desirable.
• Strong troubleshooting, communication, and cross-functional collaboration skills.

Responsibilities

• Support qualification, and startup of downstream processing equipment and systems.
• Lead troubleshooting and optimization of chromatography skids and columns.
• Partner with Manufacturing, MSAT, Validation, Quality, and Engineering teams to ensure successful process transfer and commercial readiness.
• Provide on-floor technical support/troubleshooting support during engineering, validation, and commercial manufacturing campaigns.
• Author and review SOPs, batch records, protocols, and technical reports.

Skills

7+ years of downstream bioprocessing

Troubleshooting

Communication

Cross-functional collaboration

Process transfer

Education

Bachelor's degree in Chemical Engineering, Biochemical Engineering, Biotechnology, or related field

Tools

Chromatography systems

Filtration systems

Job description

ZP Group is seeking a Downstream Process Engineer to lead the startup and commissioning of a new commercial-scale biopharmaceutical facility. You will oversee downstream purification startup, qualification, technology transfer, and ensure operational excellence, partnering with Manufacturing, MSAT, Validation, Quality, and Engineering teams.

The role requires a Bachelor's degree in a related field and 7+ years of GMP bioprocessing experience, with strong troubleshooting and cross-functional