Packaging Specialist

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.

About the Job

Title of the Position: Packaging Specialist

Responsibilities

• Packaging Development & Validation
• 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.
• Coverage of 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.
• Coverage of coordination with suppliers and contract printers to ensure compliance with approved artwork and specifications.
• Coverage of review and approval of 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.
• Participation in CAPA, risk assessments, and continuous improvement initiatives.
• Ensure proper reconciliation and accountability of printed labels and packaging components.
• Coverage of support for line clearance activities and label issuance controls to prevent mix-ups.
• Supplier and Material Management
• Qualify and manage packaging material and label suppliers.

Requirements

• Legally authorized to be employed in the United States (U.S. citizens or national, permanent residents).
• Able to successfully complete a drug and background check.
• Able to 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

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.