Aseptic Process Engineer

Job description

**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. **Job Location:** Nivagen Pharmaceuticals Inc., Sacramento, CA 3900 Duckhorn Dr, Sacramento, CA 95834. **About the Job:** **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 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. **Required Knowledge/Skills/Abilities:** - Strong understanding of aseptic processing, sterile drug product manufacturing, contamination control, and cGMP requirements. - Working knowledge of formulation, sterile filtration, filling, stoppering, capping, sealing, inspection, and packaging interfaces. - Ability to troubleshoot process issues and apply structured root cause analysis tools. - Ability to analyze manufacturing data, process trends, deviations, and performance metrics. - Strong technical writing skills for investigations, reports, protocols, SOPs, batch records, and change controls. - Knowledge of process validation, cleaning validation, computerized systems, and continued process verification concepts preferred. - Strong communication, collaboration, and project execution skills. - Ability to work effectively on the manufacturing floor and with cross-functional teams in a fast-paced GMP environment. - Proficiency with Microsoft Word, Excel, PowerPoint, and data analysis tools. **Education and Experience:** - Bachelor’s degree in chemical engineering, Biochemical Engineering, Biomedical Engineering, Mechanical Engineering, Pharmaceutical Sciences, Life Sciences, or related technical discipline required. - Advanced degree in engineering, pharmaceutical sciences, biotechnology, or related discipline preferred. - Minimum of 3–5 years of experience in pharmaceutical, biotechnology, biologics, medical device, or regulated manufacturing environment preferred. - Experience supporting sterile manufacturing, aseptic fill/finish, formulation, process engineering, MSAT, validation, or technical operations strongly preferred. - Experience with aseptic processing for vials, prefilled syringes, cartridges, or flexible containers/bags preferred. - Experience supporting deviations, CAPAs, change controls, process validation, or technology transfer in a GMP environment preferred. **Physical Requirements/ Working Conditions:** - Ability to sit, stand, walk, bend, reach, and climb stairs as needed to support manufacturing and engineering activities. - Ability to work at a computer workstation for extended periods. - Ability to enter manufacturing suites, cleanrooms, packaging areas, utility spaces, and equipment rooms as required. - Ability to wear required PPE and cleanroom gowning for extended periods when supporting classified areas. - Ability to visually inspect equipment, materials, documentation, process conditions, and computer screens. - Ability to lift, carry, push, or pull materials, laptops, sample containers, or equipment components up to 25 pounds as needed. - Ability to work overtime, weekends, holidays, alternative shifts, or on-call support as business needs require. **Work Environment** - Work is performed in a GMP pharmaceutical manufacturing facility, including office areas, cleanrooms, manufacturing suites, packaging areas, laboratories, equipment rooms, and utility spaces. - The role may require entry into Grade A, B, C, D, and controlled support areas depending on process and production needs. - Work may occur near operating equipment, automated machinery, disinfectants, production materials, controlled temperatures, and cleanroom environments. - Strict adherence to GMP, safety, gowning, hygiene, contamination control, and documentation procedures is required. - This position requires regular on-site presence; limited remote work may be possible depending on business needs and company policy. **Schedule / Shift Requirements** - Standard business hours are typical, but support may be required outside normal hours based on production needs. - Overtime, weekends, holidays, shutdown coverage, and on-call support may be required. - Must be able to support urgent process issues, manufacturing campaigns, validation activities, engineering runs, and planned production or maintenance windows. **Requirements:** - Valid driver’s license and acceptable driving record - Legally authorized to be employed in the United States (U.S. citizens or national, permanent residents) - Must live or willing to move to Sacramento Metropolitan Region (Approx. 40 miles’ radius) **Benefits:** - Competitive Salary (Based on Experience) - Yearly bonus eligibility - Benefits: Nivagen offers a wide variety of benefits and programs to support health and well-being Medical, dental and vision coverage - Paid time off plan **Additional Information:** Nivagen to afford equal opportunity for employment to all individuals regardless of race, color, age, national origin, physical or mental disability, history of disability, ancestry, citizenship status, political affiliation, religion, gender, transgender, gender identity, marital status, status as a parent, sexual orientation, veteran status, genetic information or other factors prohibited by law, and to prohibit harassment or retaliation based on any of these factors.