Aseptic Process Engineer

Aseptic Process Engineer

Nivagen Pharmaceuticals Inc., Sacramento, CA

3900 Duckhorn Dr, Sacramento, CA 95834.

Job Title:

Aseptic Process Engineer

Department:
Manufacturing Science & Technology

Reports to:

Process Engineering Manager

Job Summary:

The Aseptic Process Engineer is responsible for providing technical process ownership and engineering support for sterile pharmaceutical manufacturing operations in a cGMP-regulated environment. This role supports aseptic formulation, sterile filtration, filling, stoppering, capping, sealing, inspection, and packaging processes for vials, prefilled syringes, cartridges, and flexible containers/bags.

The Aseptic Process Engineer partners with Manufacturing, Quality Assurance, Validation, Engineering, Maintenance, Automation, Supply Chain, and Technical Operations to ensure aseptic processes are robust, compliant, efficient, and maintained in a state of control. This position supports process troubleshooting, deviation investigations, CAPAs, change controls, process validation, media fills, technology transfer, equipment/process improvements, and contamination control initiatives.

This role requires strong technical knowledge of aseptic processing, sterile drug product manufacturing, cGMP requirements, contamination control, process validation, and manufacturing floor execution in classified cleanroom environments.

Responsibilities:

• Provide technical support for aseptic manufacturing processes including formulation, sterile filtration, product transfer, aseptic filling, stoppering, capping, sealing, and related fill/finish operations.
• Support sterile drug product formats including vials, prefilled syringes, cartridges, and flexible containers/bags.
• Serve as a technical resource for Manufacturing during batch execution, process setup, line start-up, changeover, and shutdown activities.
• Evaluate process performance and identify opportunities to improve robustness, yield, throughput, right-first-time execution, and contamination control.
• Support process readiness activities including procedures, batch records, training, equipment setup, materials, and critical process parameters.
• Provide technical support for operations performed in Grade A, B, C, D, and controlled manufacturing areas, as applicable.
• Support contamination control strategy implementation, including aseptic behaviors, cleanroom practices, intervention management, airflow considerations, and process risk reduction.
• Participate in aseptic process simulations, media fills, smoke studies, airflow visualization activities, and contamination control assessments.
• Assess process interventions, line design, personnel interactions, material movement, and equipment interactions for contamination risk.
• Partner with Manufacturing, Microbiology, Quality Assurance, and Validation to investigate environmental monitoring trends, sterility-related events, and aseptic process concerns.
• Monitor process performance using batch data, process parameters, yield data, reject trends, downtime data, and quality metrics.
• Troubleshoot process issues and provide technical recommendations during manufacturing interruptions, equipment challenges, or batch deviations.
• Perform data analysis to identify trends, root causes, and improvement opportunities.
• Support process optimization activities for formulation, fill volume control, filtration, product transfer, component handling, and filing performance.
• Develop and implement process improvements to reduce deviations, improve efficiency, and maintain product quality.
• Lead or support technical investigations for deviations, process excursions, contamination events, equipment-related events, batch interruptions, and quality issues.
• Perform root cause analysis using appropriate tools and document technical assessments in accordance with site quality procedures.
• Develop, implement, and verify corrective and preventive actions related to aseptic manufacturing processes.
• Initiate, assess, and execute change controls for process improvements, equipment modifications, procedural changes, and new product/process introductions.
• Ensure technical conclusions, impact assessments, and risk evaluations are well documented and aligned with GMP expectations.
• Support process validation, cleaning validation, sterilization validation, filter validation, and continued process verification activities as applicable.
• Author, review, and execute validation-related documents including protocols, reports, process risk assessments, sampling plans, and summary reports.
• Support process performance qualification, engineering runs, media fills, and commercial process monitoring.
• Evaluate validation data and process capability to ensure processes remain in a state of control.
• Partner with Validation, Quality, Manufacturing, and Engineering to maintain process validation lifecycle documentation.
• Support technology transfer and new product introduction activities for sterile drug product manufacturing processes.
• Translate process requirements into manufacturing…