Packaging Specialist

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: Packaging Specialist We are seeking a highly skilled and experienced Packaging Specialist to join our Manufacturing Science and Technology (MSAT) team. The Packaging Specialist is responsible for the development, qualification, implementation, and continuous improvement of pharmaceutical packaging, labeling, and printing systems. This role ensures that packaging materials, labels, and printed components comply with regulatory requirements, product specifications, and quality standards while supporting manufacturing, commercialization, and supply chain activities. This role requires a strong background in packaging design, development, and troubleshooting, combined with expertise in cross-functional collaboration to deliver technical solutions in a fast-paced, dynamic environment. **Responsibilities:** **Packaging Development & Validation** · Develop, evaluate, and qualify primary and secondary packaging systems for pharmaceutical products. · Support packaging process validation, equipment qualification (IQ/OQ/PQ), and packaging line trials. · Prepare and maintain packaging specifications, user requirement specifications (URS), drawings, bills of materials (BOMs), master batch packaging records, and other technical documentation. · Conduct packaging compatibility, stability, and transportation studies. **Labeling and Artwork Management** · Create, review, and approve product labels, carton artwork, package inserts, and printed packaging components. · Coordinate artwork revisions and label updates through the change control process. · Verify barcode, serialization, lot number, expiration date, and variable data requirements. · Support implementation of new product launches and market-specific labeling requirements. · Maintain label specifications, master artwork files, and controlled documentation. **Printing Operations Support** · Support qualification, validation, and routine operation of label printing and coding systems. · Oversee printing of labels, cartons, package inserts, and variable data on packaging lines. · Verify print quality, readability, barcode compliance, and label accuracy. · Troubleshoot printing, coding, and label application issues during manufacturing. · Coordinate with suppliers and contract printers to ensure compliance with approved artwork and specifications. · Review and approve label proofs and printed samples before production. **Regulatory Compliance** · Ensure packaging and labeling systems comply with FDA, EMA, USP, cGMP, ICH, and other applicable regulations. · Support regulatory submissions by providing packaging and labeling documentation. · Assess packaging and labeling changes through formal change control processes. **Quality and Risk Management** · Investigate packaging, labeling, and printing deviations, non-conformances, and customer complaints. · Participate in CAPA, risk assessments, and continuous improvement initiatives. · Ensure proper reconciliation and accountability of printed labels and packaging components. · Support line clearance activities and label issuance controls to prevent mix-ups. **Supplier and Material Management** · Qualify and manage packaging material and label suppliers. **Education/Experience:** · Bachelor's or Master's degree in Packaging Engineering, Pharmaceutical Sciences, Industrial Engineering, Life Sciences, Chemistry, or a related technical discipline required. · Minimum 3–7 years of experience in pharmaceutical, biotechnology, medical device, or other regulated industries, with a focus on packaging operations, development, and commercialization. · Experience with sterile products, injectable products, and/or combination products preferred. · Experience with packaging validation, qualification protocols, change control, and lifecycle management activities. · Familiarity with Design History Files (DHF), risk management documentation, and combination product regulatory requirements. · Proficiency in Microsoft Office applications and ERP systems (e.g., SAP). **Knowledge and Skills:** - Knowledge of cGMP, FDA, EU GMP, ICH, and pharmaceutical packaging regulations. - Experience with packaging materials such as IV bags, vials, syringes, cartons, labels, and tamper-evident systems. - Strong understanding of packaging equipment and manufacturing processes. - Proficiency in technical writing and documentation. - Strong analytical, problem-solving, and project management skills. - Effective communication and cross-functional collaboration abilities. Proven track record of successful development and commercialization of sterile dosage forms. - Strong leadership, project management, and organizational skills. - Knowledge of serialization, aggregation, and labeling requirements. - Experience with transportation qualification and package integrity testing. - Familiarity with SAP, TrackWise, or other quality management systems. **Requirements:** - Legally authorized to be employed in the United States (U.S. citizens or national, permanent residents) - Must live or be willing to move to the Sacramento Metropolitan Region (Approx. 40 miles’ radius) - Able to successfully complete a drug and background check - Stand, walk, and perform tasks for extended periods, lift and move products up to 35 kg, and demonstrate good hand-eye coordination and fine motor skills for inspection and packing duties. - Must comply with cleanroom protocols, gowning, and PPE requirements. - The role requires strong attention to detail, the ability to identify defects or discrepancies, a strong understanding of quality control and packaging requirements, the capacity to work efficiently in a fast-paced environment while maintaining high standards, and good manual dexterity for handling delicate products. **Benefits:** - Pay range (Based on Experience) - Yearly bonus eligibility - Benefits: Nivagen offers a wide variety of benefits and programs to support health and well-being, including 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.