i-Pharm GxP
Specialist in US Contract and Project Delivery | Life Science GxP
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.
Seniority level Mid-Senior level
Employment type Contract
Job function
Manufacturing and Engineering
Pharmaceutical Manufacturing and Biotechnology Research
Get notified about new Process Engineer jobs in
North Carolina, United States .
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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.
Seniority level Mid-Senior level
Employment type Contract
Job function
Manufacturing and Engineering
Pharmaceutical Manufacturing and Biotechnology Research
Get notified about new Process Engineer jobs in
North Carolina, United States .
#J-18808-Ljbffr