Nivagen Pharmaceuticals, Inc. · 2 months ago
Sterile Manufacturing Associate
Sacramento, CA 95834
Full-time
Onsite
New Grad, Entry Level
$28/hr - $35/hrNivagen Pharmaceuticals is a global company dedicated to enhancing lives through cost-effective generic prescription drugs. The Sterile Manufacturing Associate is responsible for executing aseptic and cleanroom manufacturing operations, ensuring the integrity and quality of sterile drug products in compliance with regulatory standards and internal SOPs.
ManufacturingMarket ResearchPharmaceutical
Responsibilities
Perform aseptic manufacturing operations in Grade A, B, C, and D cleanroom environments, including formulation, filtration, filling, and visual inspection
Set up, operate, and clean equipment such as vial/syringe fillers, autoclaves, and isolators under sterile conditions
Comply with all gowning requirements and environmental control procedures to maintain sterile conditions
Follow batch production records (BPRs), standard operating procedures (SOPs), and material handling protocols
Support execution of media fills, process validations, and cleanroom qualification activities
Participate in room and equipment sanitization activities, ensuring compliance with established cleaning frequencies
Complete all training in a timely manner and maintain qualification for aseptic operations
Accurately record all activities in cGMP documentation, ensuring data integrity
Assist with investigations, deviations, CAPAs, and continuous improvement initiatives
Collaborate with Quality, Validation, Engineering, and Tech Services as needed to ensure successful production runs
Follow safety, health, and environmental policies and procedures
Qualification
Required
High School diploma or GED required
Valid driver's license and acceptable driving record
Legally authorized to be employed in the United States
This role is an onsite role and requires daily commuting to and from the facility
This role requires work in a controlled cleanroom environment with strict gowning and hygiene protocols
Must be able to stand for extended periods, lift up to 50 pounds, and perform repetitive tasks
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
Ability to work independently and as part of a collaborative team
Willingness to work flexible shifts and weekends as required by production schedule
Preferred
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
Benefits
Annual Bonus eligibility
Medical, Dental and Vision coverage
PTO plan
401K plan
Company
Nivagen Pharmaceuticals, Inc.
Nivagen is engaged in the development, acquisition and sales of generic prescription drugs and over the counter products for the North American market.
Founded in 2009
11-50 employees
H1B Sponsorship
Nivagen Pharmaceuticals, Inc. has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (19)
2024 (19)
2023 (15)
2022 (5)
2021 (11)
2020 (7)
Funding
Current Stage
Early StageTotal Funding
$31MKey Investors
Telegraph Hill Partners
2026-01-06Acquired
2023-08-09Series Unknown· $5M
2020-05-19Series Unknown· $16M
Recent News
Bizjournals.com Feed (2025-11-12 15:43:17)
2026-01-07
2025-05-23
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