Manufacturing Associate

Manufacturing Associate

Nivagen Pharmaceuticals LLC, Sacramento, CA, 3900 Duckhorn Dr, Sacramento, CA 95834

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:

• Operate in ISO environments performing essential duties to manufacturing sterile products.
• Installation, qualification of the Formulation, filtration, Autoclave, Bag filling, PFS filling, combi filling and Isolator, in co-ordination with machine manufacturers and cross functional departments.
• Cleaning, Operation, change over, assembling, disassembling of the machine parts for the bag filling, PFS filling and combi filling machines.
• Cleaning, operation, loading, unloading of the Autoclave.
• Cleaning, operation, operation of formulation and filtration vessel by performing the PHT (pressure Hold test), Clean In Place (CIP), Filter wetting and integrity, Sterilization In Place (SIP), batch processing.
• Routine manufacturing operations like manufacturing, filling, Autoclave, visual inspection and packing operations.
• Assist and perform compounding, verifying steps, aseptic processing, container closure, integrity testing, inspecting units for foreign matter, labeling, packaging.
• Complete manufacturing documentation and necessary document control assignments.
• 100% Visual inspection and AQL inspection.
• Competent to perform duties as outlined for material transfer, aseptic processing, and other cleanroom related duties.
• To follow the aseptic behaviour in ISO clean rooms by following adequate gowning procedures.
• To follow and record the online documentation to record the activities in respective batch records and logbooks.
• Perform cleanroom environmental monitoring, cleaning and disinfection, and sterilization techniques.
• Assist with investigations, for compounding, filling, autoclave, terminal sterilization and packing reports, audits and/or complaints.
• Knowledge of compounding terminology and calculations
• Other duties as assigned by management or quality assurance.
• Ability to learn and perform pharmaceutical level visual inspection.
• Work in controlled environments and wear personal protective equipment, as necessary.
• Cleaning and maintaining of the ISO clean rooms and online documentation of the activities.
• To follow the GMP, GDP, ALCOA+++, FDA and regulatory guidelines at all times.

Qualifications:

• Knowledge and experience in cGMP and FDA 21 CFR parts 210 and 211
• Experience participating in a Manufacturing Unit in an FDA approved GMP facility that includes cGMP compliance and sterile product preparation for pharmaceuticals.
• Hands on experience and skills to handle the formulation, filtration, filling, autoclave and terminal sterilizer and packing equipment's.
• Thorough knowledge on the FDA guidelines for manufacturing of the sterile drug products manufacturing.
• Knowledge on the Sterilization, aseptic behaviour, disinfection and sanitization of the clean rooms and its supporting areas.
• Sterile Manufacturing and filling activities.

Education/Experience:

Undergraduate/Graduate

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.