Sterile Manufacturing Associate

Nivagen Pharmaceuticals Inc; Sacramento (CA); On-site; USD 39,000 - 44,000; Full time

Benefits offered by this job

Fulltime Employment

Annual Bonus eligibility

Medical, Dental, and Vision coverage

PTO plan

401K plan

Job summary

Nivagen Pharmaceuticals Inc in Sacramento, CA is seeking a Manufacturing Associate to execute aseptic and cleanroom manufacturing operations in compliance with cGMP, regulatory standards, and internal SOPs. The role requires strict gowning, precise procedures, and strong attention to detail.

The position involves operating vial/syringe fillers, autoclaves, and isolators, following BPRs, SOPs, and material handling protocols.

Qualifications

• Must read and follow SOPs, batch records, and manufacturing instructions precisely.

Responsibilities

• Perform aseptic manufacturing in Grade A–D cleanrooms including formulation, filtration, filling, and inspection.
• Set up, operate, and clean vial/syringe fillers, autoclaves, and isolators under sterile conditions.
• Follow gowning and environmental control procedures to maintain sterile conditions.
• Adhere to batch production records (BPRs) and SOPs; manage material handling protocols.
• Support media fills, process validations, and cleanroom qualifications.
• Assist with room/equipment sanitization and cleaning frequency checks.
• Complete training timely and maintain aseptic operation qualifications.
• Record activities in cGMP documentation with data integrity.
• Assist investigations, deviations, CAPAs, and continuous improvement.
• Collaborate with Quality, Validation, Engineering, and Tech Services as needed.
• Adhere to safety, health, and environmental policies.

Skills

Aseptic technique

Cleanroom behavior

SOPs & batch records

Documentation & communication

Independent & team work

Willingness to flexible shifts

Education

High School diploma or GED

Tools

Gowning procedures

Job description

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 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. 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 the production schedule.

Requirements

• Valid driver’s license and acceptable driving record.
• Legally authorized to be employed in the United States.
• This role is an on-site 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 - $32 per hour based on shift. 1st (6:00 am- 2:30 pm)/ 2nd (2:30 pm- 10:00 pm)
• Annual Bonus eligibility
• Medical, Dental, and Vision coverage
• PTO plan
• 401K plan

Additional Information

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.