Aseptic Process Engineer: Lead Sterile Fill/Finish Innovator

Nivagen Pharmaceuticals; Sacramento (CA); On-site; USD 100,000 - 150,000; Full time

Benefits offered by this job

Medical, dental and vision coverage

Paid time off plan

Job summary

Nivagen is seeking an Aseptic Process Engineer in Sacramento to lead technical ownership of sterile manufacturing operations in a cGMP setting. Responsibilities include aseptic formulation, sterile filtration, filling, stoppering, capping, sealing, inspection, and packaging for vials, prefilled syringes, cartridges, and flexible containers.

You will collaborate with Manufacturing, QA, Validation, Engineering, and Maintenance to ensure compliant, robust processes.

Qualifications

• Bachelor’s degree in chemical engineering, biochemical engineering, biomedical engineering, mechanical engineering, pharmaceutical sciences, life sciences, or related.
• Minimum 3–5 years in pharmaceutical manufacturing.
• Experience with aseptic processing and sterile fill/finish preferred.

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 instructions, equipment needs, facility requirements, batch records, and process parameters.
• Participate in process fit assessments, gap assessments, risk assessments, and manufacturing readiness reviews.
• Support engineering runs, clinical or commercial scale-up, process comparability assessments, and launch readiness activities.
• Collaborate with development, MSAT, Quality, Validation, Supply Chain, and Manufacturing to ensure successful process implementation.
• Provide process engineering support for aseptic processing equipment, including isolators, Restricted Access Barrier Systems, filling lines, pumps, filtration systems, stopper/cap handling systems, bag filling systems, and related support equipment.
• Support equipment design reviews, user requirements, commissioning, qualification, FAT/SAT, and operational readiness activities.
• Partner with Maintenance, Automation, Facilities, and Engineering to resolve process-equipment interface issues.
• Support process requirements for cleanrooms, utilities, environmental controls, sterilization/decontamination systems, and product-contact equipment.
• Help define and maintain process-critical equipment parameters, alarms, recipes, and operational limits.
• Author and review GMP documents including SOPs, batch records, protocols, technical reports, change controls, deviations, CAPAs, risk assessments, and process descriptions.
• Ensure process documentation accurately reflects approved manufacturing processes and current operational practices.
• Support documentation updates related to process improvements, investigations, validation outcomes, and regulatory commitments.
• Maintain compliance with cGMP, GDP, data integrity, validation, and company quality system expectations.
• Support regulatory inspections, customer audits, internal audits, and inspection readiness activities as needed.
• Partner with Manufacturing, Quality Assurance, Quality Control, Validation, Engineering, Maintenance, Automation, Supply Chain, and Technical Operations to resolve process-related issues.
• Provide technical training and process knowledge transfer to Manufacturing Technicians, Supervisors, and support teams.
• Participate in production meetings, tier meetings, deviation review boards, validation meetings, and project meetings.
• Communicate process risks, technical recommendations, and project status clearly to stakeholders.
• Promote a culture of safety, quality, compliance, and continuous improvement.

Skills

Aseptic processing

cGMP

Troubleshooting

Data analysis

Documentation

MS Office

Education

Bachelor’s in Chemical/Pharma

Advanced degree preferred

Tools

Validation systems

MS Office

Job description

Nivagen is seeking an Aseptic Process Engineer in Sacramento to lead technical ownership of sterile manufacturing operations in a cGMP setting. Responsibilities include aseptic formulation, sterile filtration, filling, stoppering, capping, sealing, inspection, and packaging for vials, prefilled syringes, cartridges, and flexible containers.

You will collaborate with Manufacturing, QA, Validation, Engineering, and Maintenance to ensure compliant, robust processes.