Process Engineer Upstream/Downstream Manufacturing

Process Engineer -

Upstream/Downstream Manufacturing Location:

Holly springs,

NC Duration:

12+months Job Summary We are looking for self-driven Process Engineers with strong biopharmaceutical manufacturing experience to support a greenfield expansion project in North Carolina. Candidates should possess hands-on expertise in upstream and downstream process operations, equipment startup, troubleshooting, and process optimization within GMP environments. Key Responsibilities Support startup, commissioning, and operational readiness activities for manufacturing process systems. Provide technical support for upstream and downstream operations. Assist with equipment qualification, process troubleshooting, and engineering investigations. Collaborate with CQV, manufacturing, automation, and quality teams. Review process flow diagrams, P&IDs, batch records, and technical documentation. Support scale-up, tech transfer, and process optimization activities. Ensure compliance with GMP standards and safety procedures. Participate in FAT/SAT, engineering walkdowns, and turnover activities. Support deviation resolution and CAPA implementation. Required Experience 5+ years of Process Engineering experience in biotech or pharmaceutical manufacturing.

Strong experience with:

Upstream bioprocessing Downstream purification Bioreactors Chromatography systems Filtration systems CIP/SIP operations Experience supporting greenfield or large capital projects. Knowledge of GMP manufacturing operations and validation practices. Ability to work independently in fast-paced project environments. Preferred Qualifications Experience with biologics manufacturing facilities. Familiarity with automation/control systems. Strong troubleshooting and process optimization capabilities. Bachelor's degree in Chemical Engineering, Mechanical Engineering, Biotechnology, or related field.

Pay:

$45.00 - $50.00 per hour

Work Location:

In person