Aseptic Process Engineer

About the Company:

Nivagen is a global company dedicated to enhancing lives by developing and providing cost-effective generic prescription drugs and over-the-counter products for the North American market. For over a decade, we've remained steadfast in our commitment to core values of excellence, integrity, and respect for people. Our team of professionals collaborates tirelessly to pioneer advancements in manufacturing, distribution, and quality control, ensuring a holistic approach to healthcare.

Through vertical integration of the pharmaceutical supply chain, cutting-edge technology, and unwavering dedication to excellence, we continually strive to redefine medication accessibility and affordability. We prioritize our employees' well-being by offering competitive pay, comprehensive benefits, and robust training and development opportunities. By investing in our workforce and fostering a culture of growth and support, we empower our team to drive innovation and make a positive impact in the healthcare industry.

At Nivagen, our mission is clear: to make a meaningful difference in people's lives by delivering high-quality, affordable medications while upholding the highest standards of integrity and excellence.

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.

• 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…