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.
Compensation for the Process Engineer:
- Salary Range : $75-$84/hour
- Comprehensive Benefits : Sick leave if required by law, medical, dental, vision, 401K
This job opens for applications on 08/11/2025. Applications for this job will be accepted for at least 30 days from the posting date. Keywords: Process Engineer, Biologics Manufacturing, Upstream Operations, GMP, Process Qualification, PQ, Bioreactor, Cell Culture, Startup Facility, Manufacturing Support, Equipment Qualification, Water Runs, Cross-functional Collaboration, CQV, Maintenance Coordination, Quality Systems, Troubleshooting, Technical Liaison, Engineering Degree, Chemical Engineering, Biotechnology, Pharmaceutical Engineering, Chromatography, Depth Filtration, Validation Support, Manufacturing Run, Operational Readiness, Facility Startup, Hands-on Support #LI-GP2 #LI-ONSITE