Nivagen Pharmaceuticals, Inc.

Sterile Manufacturing Associate

Sacramento, CA 95834 · Full-time

Sponsorship not specified$28k-$32kDetected 7 hours ago

AccessibilitySupply ChainGMPCommunication

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.
This role plays a critical part in ensuring the integrity and quality of sterile drug products manufactured at Nivagen.

Perform aseptic manufacturing operations in Grade A, B, C, and D cleanroom environments, including formulation, filtration, filling, and visual inspection.
Comply with all gowning requirements and environmental control procedures to maintain sterile conditions.
Support execution of media fills, process validations, and cleanroom qualification activities.
Complete all training in a timely manner and maintain qualification for aseptic operations.
Collaborate with Quality, Validation, Engineering, and Tech Services as needed to ensure successful production runs.

Must be able to stand for extended periods, lift up to 50 pounds, and perform repetitive tasks.
Knowledge, Skills, and Abilities:
The position requires a high degree of attention to detail, adherence to gowning and aseptic techniques, and the ability to follow precise procedures.
Education/Experience:
Ability to work independently and as part of a collaborative team.

High School diploma or GED required
Associate's or Bachelor's degree in Life Sciences or related field preferred.
Experience in an aseptic or sterile pharmaceutical manufacturing environment preferred.
Experience in cGMP-regulated environments is highly desirable.

Strong understanding of aseptic technique, cleanroom behavior, and contamination control.
Ability to read and follow SOPs, batch records, and manufacturing instructions precisely.
Comfortable wearing full aseptic gowning (hoods, coveralls, gloves, booties, masks) for extended periods.
Detail-oriented with strong documentation and communication skills.
Willingness to work flexible shifts and weekends as required by the production schedule.

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.
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.
to make a meaningful difference in people's lives by delivering high-quality, affordable medications while upholding the highest standards of integrity and excellence.
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: Manufacturing Associate
The Manufacturing Associate is responsible for executing aseptic and cleanroom manufacturing operations in compliance with cGMP, regulatory standards, and internal SOPs.

Nivagen Pharmaceuticals affords 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.

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

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