Production Technician

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: Production Technician

At Nivagen as a Production Technician you will be responsible for manufacturing the drug products intended for human use. You will be performing associated tasks in critical and non-critical environments such as equipment operation, cleaning, maintenance, environmental monitoring, and other various tasks relating to the production department

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 terminal sterilizer, 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 and Terminal sterilizers
• 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, terminal sterilizer, 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 behavior 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 always

Qualifications:

Education/Experience:

• Bachelor’s degree
• A minimum of 2 years sterile compounding experience needed

Knowledge, Skills, and Abilities:

• 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 behavior, disinfection and sanitization of the clean rooms and its supporting areas
• Hands on Sterile Manufacturing and filling activities

Requirements:

• Valid driver’s license and acceptable driving record
• Legally authorized to be employed in the United States
• Must live or willing to move to Sacramento Metropolitan Region (Approx. 40 miles’ radius)

Benefits:

• Fulltime
• $28.0 -$35.0/Hour (Based on Experience)
• Yearly bonus eligibility
• Benefits: Nivagen offers a wide variety of benefits and programs to support health and well-being
• Medical, dental and vision coverage
• Paid time off plan
• 401k savings plan

Additional Information:

Nivagen to afford 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