Process Engineer

A leading life sciences client in North Carolina is seeking an experienced Technical Filling Process Engineer to support aseptic manufacturing operations and capital project execution. This is a W2 contract role, initially 12 months, with extension subject to performance and ongoing project requirements.

Responsibilities

• Provide technical ownership of aseptic filling processes supporting clinical and commercial manufacturing operations.

• Support the installation, start up, and optimisation of automated filling lines, with a focus on Optima or Groninger equipment.

• Lead and support media fills, process simulations, and aseptic interventions in accordance with GMP requirements.

• Troubleshoot filling line performance issues including throughput, yield, and sterility assurance.

• Collaborate with engineering, validation, quality, and operations teams during commissioning, qualification, and routine manufacturing.

• Support development and execution of process validation protocols and technical documentation.

• Ensure filling operations comply with cGMP, aseptic processing guidelines, and internal procedures.

• Act as a technical point of contact for equipment vendors and external partners.

Experience Required

• Proven experience as a Technical or Process Engineer supporting aseptic filling operations in a life sciences environment.

• Hands on experience with automated filling lines, specifically Optima or Groninger systems.

• Strong understanding of aseptic processing principles, sterility assurance, and contamination control strategies.

• Experience supporting media fills, process validation, and GMP manufacturing activities.

• Familiarity with commissioning and qualification activities for filling equipment.

• Ability to troubleshoot complex process and equipment related issues in a fast paced manufacturing setting.

• Strong communication skills and ability to work cross functionally on site in North Carolina.