Aseptic Process Engineer

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.

Nivagen Pharmaceuticals Inc., Sacramento, CA

3900 Duckhorn Dr, Sacramento, CA 95834.

• →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 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.

• 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)

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.