Nivagen Pharmaceuticals, Inc.
Validation Engineer - Pharmaceutical Sterile Manufacturing
Sacramento, CA 95834
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odds of building a lasting career here
Sponsors, but it's cap-subject — you still face the weighted lottery (~30% per draw at Level II). Good if you win; have a cap-exempt backup on your list.
Lottery odds assume a STEM candidate.
Personalize to your clock →H-1B wage level
the lottery is wage-weighted — each level is one more entry
$7,136 more — $97,136 — moves this role to Level II and 2 lottery entries. That figure is inside the range the employer already advertised.
Based on the DOL prevailing wage for this occupation and worksite, a base salary of $97,136 would place this position at wage Level II. That figure is within the posted range, and I'd like to target it. This role classifies under "Industrial Engineers" for prevailing-wage purposes.
DOL prevailing wage, 2026-27 wage year · Industrial Engineers (17-2112) · Sacramento-Roseville-Folsom, CA. Wage level is derived by USCIS from the offered wage, occupation and worksite; the occupation shown is inferred from the job title.
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from this employer's Department of Labor filings
Files H-1B transfers
Sourced from Department of Labor LCA, PERM and prevailing-wage disclosure data. Employer matching is by name, so figures may be split across an employer's legal entities. Absence of a filing means none appears in our copy of the data, not that none exists.
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About the role
- 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.
Responsibilities
- Perform or oversee the Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) of new and existing equipment and systems.
- Maintain traceability of validation activities and ensure all validation records are accurately documented, maintained, and stored.
- Conduct and manage process validation studies to confirm the sterility and quality of pharmaceutical products.
- Work with cross-functional teams (e.g., production, quality control, engineering) to optimize manufacturing processes and ensure consistency and repeatability.
- Support the development and implementation of new processes, ensuring that they are validated per regulatory requirements.
- Perform any additional tasks as assigned by the Validations Lead
- 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.
Requirements
- Bachelor's degree or Diploma in Pharmaceuticals, or a related field.
- Minimum 2 years of experience in a pharmaceutical manufacturing or validation role, with a focus on sterile manufacturing (e.g., aseptic processing, sterile filling, isolator, autoclave sterilization).
- Strong understanding of cGMP, FDA, EMA, ISO standards, and other relevant regulatory requirements.
- Experience with equipment validation (e.g., filling machines, autoclaves, and HVAC systems) and process validation.
- Familiarity with the documentation requirements for validation, including protocol development, execution, and report writing
- Knowledge, Skills, and Abilities:
- Familiarity with data analysis tools and software used for validation testing and reporting (e.g., Excel, Validation Master Plans, LIMS systems).
Skills
- Excellent technical writing and documentation skills.
- Ability to work cross-functionally and manage multiple priorities.
- Aseptic processing or sterile manufacturing practices.
Compensation
- $90k-$110k
Benefits
- 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
- 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.
Company info
- 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 LLC, Sacramento, CA
- 3900 Duckhorn Dr, Sacramento, CA 95834
- About the Job:
- Title of the Position: Validation Engineer
- At Nivagen as a Validation Engineer you will be responsible for ensuring that manufacturing processes, equipment, utilities, and systems in the sterile pharmaceutical production environment meet all regulatory requirements, industry standards, and company specifications.
- The role involves independently working and supporting the validation lifecycle from installation through qualification and routine re-validation activities, ensuring that the company's sterile manufacturing processes are in compliance with cGMP (current Good Manufacturing Practices) and other regulatory guidelines such as FDA, EMA, and ISO standards.
Visa & Work Authorization
- iduals 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 s
This listing is sourced directly from Nivagen Pharmaceuticals, Inc.'s careers page and normalized into a canonical job model.