Nivagen Pharmaceuticals, Inc.

Nivagen Pharmaceuticals, Inc.

Aseptic Process Engineer

Sacramento, CA 95834 · Mid

Sponsorship not specifiedDetected 26 days ago
AirflowData AnalysisAccessibilityExcelSupply ChainProcess ImprovementCustomer SupportMechanical DesignGMPMedical DevicesCommunicationCollaborationWritingMicrosoft Office

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odds of building a lasting career here

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Cap-exempt (no lottery)0
Sponsors this role90
Entry-level history0
PERM / green-card track0
Lottery odds40
Fits your clock70

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Employer immigration record

from this employer's Department of Labor filings

Files H-1B transfers

7 transfer filings in the last year, covering 7 workers. Median labor-condition decision: 7 days. An employer that already files transfers is one that can take over an existing H-1B.

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About the role

  • 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.
  • This position supports process troubleshooting, deviation investigations, CAPAs, change controls, process validation, media fills, technology transfer, equipment/process improvements, and contamination control initiatives.

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 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.
  • 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.
  • 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.
  • 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.

Nice to have

  • 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.
  • Experience supporting sterile manufacturing, aseptic fill/finish, formulation, process engineering, MSAT, validation, or technical operations strongly preferred.
  • Experience with aseptic processing for

Skills

  • 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.

Benefits

  • Our team of professionals collaborates tirelessly to pioneer advancements in manufacturing, distribution, and quality control, ensuring a holistic approach to healthcare.
  • 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.
  • Support sterile drug product formats including vials, prefilled syringes, cartridges, and flexible containers/bags.

Company info

  • For over a decade, we've remained steadfast in our commitment to core values of excellence, integrity, and respect for people.
  • 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.
  • 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
  • Reports to: Process Engineering Manager
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