Piper Companies is seeking a Process Engineer for an advanced biologics CDMO located in Holly Springs, North Carolina (NC). The Process Engineer will be responsible for helping lead upstream operations in a large, start-up cell manufacturing facility. This position will be on-site in Holly Springs, NC.

Responsibilities of the Process Engineer:

• Lead upstream operations support during the startup of a large-scale biologics facility, from vial thaw through harvest and into the Process Qualification (PQ) phase.
• Coordinate across manufacturing, CQV, maintenance, and quality teams to ensure equipment readiness and troubleshoot PQ-related issues.
• Support water runs, equipment modifications, and qualification activities to prepare for the first GMP manufacturing run.
• Act as a technical liaison, helping align schedules, order parts, and facilitate communication between internal teams and contractors.
• Provide hands-on support during initial manufacturing runs, contributing to process development and helping define operational procedures.
• Navigate a dynamic startup environment by proactively resolving issues, guiding cross-functional collaboration, and adapting to evolving project needs.

Qualifications for the Process Engineer:

• 8+ years of experience in upstream cell culture process development.
• Experience working with a bioreactor housing cells.
• Must have worked in a startup facility and previously supported a start to finish manufacturing process.
• Ability to understand and communicate between groups such as quality, maintenance, validation, etc.
• Degree in Chemical Engineering or another related engineering field.

• Lead upstream operations support during the startup of a large-scale biologics facility, from vial thaw through harvest and into the Process Qualification (PQ) phase.
• Coordinate across manufacturing, CQV, maintenance, and quality teams to ensure equipment readiness and troubleshoot PQ-related issues.
• Support water runs, equipment modifications, and qualification activities to prepare for the first GMP manufacturing run.
• Act as a technical liaison, helping align schedules, order parts, and facilitate communication between internal teams and contractors.
• Provide hands-on support during initial manufacturing runs, contributing to process development and helping define operational procedures.
• Navigate a dynamic startup environment by proactively resolving issues, guiding cross-functional collaboration, and adapting to evolving project needs