Sterile Manufacturing Associate

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:

Title of the Position: Sterile Manufacturing Associate

The Sterile Manufacturing Associate is responsible for executing aseptic and cleanroom manufacturing operations in compliance with cGMP, regulatory standards, and internal SOPs. This role plays a critical part in ensuring the integrity and quality of sterile drug products manufactured at Nivagen. The position requires a high degree of attention to detail, adherence to gowning and aseptic techniques, and the ability to follow precise procedures.

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.

Qualifications:

Education/Experience:

• 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.

Knowledge, Skills, and Abilities:

• 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.

Requirements:

• 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.

Benefits:

• Fulltime Employment
• $28 - $40 per hour (Based on Experience)
• Annual Bonus eligibility
• Medical, D