Jobs / United States / Nivagen Pharmaceuticals INC
Aseptic Process Engineer
Nivagen Pharmaceuticals INC · 🇺🇸 Sacramento, CA 95834
Sponsorship verdict
Sponsorship possible
One solid signal, not two — worth applying, and worth asking about sponsorship early.
- Employer is on a government sponsor recordThe US Department of Labor certified 11 H-1B/E-3 labor condition applications for this employer between Oct 2025 and Jun 2026 (latest Jun 2026) — the step every H-1B hire needs first. USCIS also records 2 H-1B approvals in FY2023. Source: LCA disclosure data (US Department of Labor (OFLC)).
- The posting doesn’t mention sponsorshipSilence isn’t a refusal — ask the recruiter before investing much time.
- No salary bar for this routeH-1B has no fixed salary bar: the employer must pay at least the prevailing wage for the role and area. Cap-subject employers enter a lottery weighted by wage level. Source: https://www.federalregister.gov/documents/2025/12/29/2025-23853/weighted-selection-process-for-registrants-and-petitioners-seeking-to-file-cap-subject-h-1b, rules effective 2026-02-27.
- What Nivagen Pharmaceuticals INC paid sponsored hires in similar roles3 certified filings for “Process Engineer Manager” (Industrial Engineers) in CA: $75k–$130k, median $130k. Most were filed at wage level III (67%) — 3 lottery entries, ≈46% projected selection odds for cap-subject employers. Source: US Department of Labor LCA disclosure data (Oct 2025 – Jun 2026).
- Confirmed live todayWhen a source last listed this job as open.
US H-1B: cap-subject employers enter a lottery weighted by wage level — Level I gets 1 entry, Level IV gets 4 (DHS projected selection odds ≈15% at Level I to ≈61% at Level IV). Universities and non-profit research employers are cap-exempt. The $100,000 fee for new petitions from abroad is currently blocked by a court order (appeal pending).
A verdict summarises public evidence; it is not legal advice and never a guarantee — the employer and the immigration authority decide. Sign in to factor in where you can already work.
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Sponsor Radar — Nivagen Pharmaceuticals INC
The US Department of Labor certified 11 H-1B/E-3 labor condition applications for this employer between Oct 2025 and Jun 2026 (latest Jun 2026) — the step every H-1B hire needs first. USCIS also records 2 H-1B approvals in FY2023. Source: LCA disclosure data (US Department of Labor (OFLC)).
Past sponsorship or register membership never guarantees sponsorship for this vacancy or for you. Full Sponsor Radar for Nivagen Pharmaceuticals INC →
About the role
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 stud