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Process Engineer

2 weeks ago

Raleigh, North Carolina, United States i-Pharm GxP Full time

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.