Manufacturing Associate 2nd Shift Only (2 PM- 10:30 PM)

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- 2nd Shift Only (2 PM-10:30 PM)

The Manufacturing Technician is responsible for performing hands-on manufacturing activities in a cGMP-regulated pharmaceutical manufacturing environment. This role supports the production of sterile pharmaceutical products through activities such as material preparation, formulation support, aseptic filling, equipment setup, cleaning, line clearance, inspection, packaging, and batch documentation. The Manufacturing Technician works in classified cleanroom and controlled manufacturing areas and is expected to follow approved procedures, maintain accurate documentation, comply with GMP requirements, and support safe, efficient, and compliant production operations.

Responsibilities:

1. GMP Manufacturing Operations

• Perform routine manufacturing activities in accordance with approved batch records, SOPs, work instructions, and cGMP requirements.
• Support production operations involving vials, syringes, cartridges, flexible containers/bags, or other sterile drug product formats.
• Assist with formulation, compounding, sterile filtration, filling, inspection, labeling, packaging, and material handling activities as assigned.
• Prepare, stage, transfer, and reconcile materials, components, equipment, and supplies required for manufacturing.
• Perform equipment setup, operation, breakdown, and cleaning activities under supervision or independently based on qualification level.

1. Aseptic and Cleanroom Operations

• Work in classified cleanroom environments, including Grade B, Grade C, Grade D, and support areas, as applicable.
• Follow proper gowning, hygiene, aseptic behavior, and contamination control practices.
• Maintain cleanroom discipline and comply with all procedures related to personnel flow, material flow, and environmental control.
• Support pre-use checks, room readiness, equipment readiness, and line clearance activities.
• Identify and escalate potential contamination risks, procedural concerns, or abnormal conditions.

1. Equipment Operation and Process Support

• Operate manufacturing and support equipment such as filling equipment, pumps, filtration systems, mixers, inspection equipment, packaging equipment, and other process-related systems.
• Perform routine equipment checks and document equipment status before, during, and after use.
• Assist with changeovers, product path assembly, tubing setup, component loading, and equipment sanitization.
• Identify routine equipment or process issues and notify the Lead Technician, Supervisor, Maintenance, or Engineering as appropriate.
• Support troubleshooting activities and corrective actions as directed.

1. GMP Documentation and Compliance

• Complete batch records, logbooks, forms, equipment records, and electronic entries accurately and in real time.
• Follow Good Documentation Practices and data integrity requirements.
• Review documentation for completeness and accuracy within assigned responsibilities.
• Report deviations, discrepancies, errors, equipment issues, and safety concerns promptly.
• Support deviation investigations, corrective actions, and audit readiness activities as needed.

1. Inspection, Packaging, and Material Handling

• Perform visual inspection, packaging, labeling, kitting, and reconciliation activities as assigned.
• Handle raw materials, components, intermediates, bulk product, and finished goods in accordance with GMP and safety requirements.
• Support product segregation, status labeling, material staging, and inventory transactions.
• Assist with serialization, labeling verification, and packaging line clearance activities where applicable.

1. Safety, Quality, and Continuous Improvement

• Follow all safety procedures, PPE requirements, chemical handling procedures, and cleanroom safety practices.
• Maintain work areas in a clean, organized, and inspection-ready state.
• Participate in 5S, continuous improvement, and operational excellence activities.
• Support right-first-time execution and help identify opportunities to improve quality, efficiency, and compliance.
• Participate in training and maintain qualification requirements for assigned tasks.

Non-Essential Functions

• Assist with inventory counts, material movement, and production support activities.
• Participate in team meetings, shift handoffs, and cross-functional discussions.
• Support SOP updates, training improvements, and process improvement initiatives.
• Perform other duties as assigned based on business needs.

Required Qualifications

Education

• High school diploma or GED required.
• Associate degree, technical certificate, or coursework in biotechnology, life sciences, manufacturing, engineering technology, or related discipline preferred.

Experience

• 0-3 years of experience in pharmaceutical, biotechnology, medical device, food, chemical, or other regulated manufacturing environment preferred.
• Prior GMP, cleanroom, aseptic processing, packaging, inspection, or manufacturing experience preferred.
• Entry-level candidates with strong attention to detail and willingness to work in a regulated environment may be considered.

Required Knowledge, Skills, and Abilities

• Ability to follow written procedures, batch records, and verbal instructions.
• Strong attention to detail and ability to complete documentation accurately.
• Basic understanding of GMP, GDP, cleanroom behavior, and safety practices preferred.
• Ability to work effectively in a team-based manufacturing environment.
• Ability to communicate issues clearly and escalate concerns appropriately.
• Ability to perform repetitive tasks while maintaining quality and accuracy.
• Basic computer skills; experience with SAP, MES, electronic batch records, or other manufacturing systems preferred.
• Willingness to work in cleanroom gowning and follow strict hygiene and contamination control requirements.

Preferred Qualifications

• Experience in sterile pharmaceutical or biologics manufacturing.
• Experience with aseptic filling, formulation, inspection, packaging, or cleanroom operations.
• Familiarity with vials, syringes, cartridges, and flexible containers/bags.
• Experience with GMP documentation, batch records, logbooks, and electronic systems.
• Experience operating manufacturing equipment in a regulated environment.
• Knowledge of 5S, Lean Manufacturing, or continuous improvement tools.

Physical Requirements

• Ability to stand and walk for extended periods during manufacturing operations.
• Ability to wear cleanroom gowning and PPE for extended periods.
• Ability to perform repetitive tasks requiring manual dexterity and attention to detail.
• Ability to lift, carry, push, or pull materials and equipment up to 25-50 pounds, in accordance with site safety procedures.
• Ability to bend, reach, stoop, kneel, climb steps, and work around manufacturing equipment.
• Ability to visually inspect materials, labels, equipment, rooms, and documentation.
• Ability to work with disinfectants, cleaning agents, and manufacturing materials while wearing required PPE.
• Ability to work overtime, weekends, holidays, or alternative shifts as required.

Work Environment

• Work is performed in a GMP pharmaceutical manufacturing facility, including cleanroom and controlled manufacturing areas.
• Work may occur in Grade B, Grade C, Grade D, warehouse, inspection, packaging, and support areas.
• The environment may include exposure to operating equipment, production materials, cleaning agents, controlled temperatures, noise, and disinfectants.
• Strict adherence to gowning, hygiene, safety, contamination control, and documentation procedures is required.
• This position requires on-site presence and is not eligible for remote work.

Schedule / Shift Requirements

• Position may be assigned to day, swing, night, compressed, or rotating shifts based on production needs.
• Overtime, weekends, holidays, and shift coverage may be required.
• Must be able to support production schedules, batch timelines, and business priorities.

Benefits:

• Fulltime Employment
• $28 - $32 per hour based on shift/experience. 
• Annual Bonus eligibility
• Medical, Dental, and Vision coverage
• PTO 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.