Nivagen Pharmaceuticals, Inc.

Nivagen Pharmaceuticals, Inc.

Packaging Specialist

Sacramento, CA 95834

Sponsorship not specifiedDetected 42 days ago
ComplianceAccessibilityProject ManagementSAPSupply ChainERPGMPFDA RegulatoryMedical DevicesLeadershipCommunicationCollaborationProblem SolvingWritingMicrosoft Office

About the role

  • For over a decade, we've remained steadfast in our commitment to core values of excellence, integrity, and respect for people.
  • 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.
  • Job Location: Nivagen Pharmaceuticals LLC, Sacramento, CA 3900 Duckhorn Dr, Sacramento, CA 95834.

Responsibilities

  • 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.
  • Create, review, and approve product labels, carton artwork, package inserts, and printed packaging components.
  • 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.
  • Support regulatory submissions by providing packaging and labeling documentation.
  • Support line clearance activities and label issuance controls to prevent mix-ups.

Nice to have

  • Bachelor's or Master's degree in Packaging Engineering, Pharmaceutical Sciences, Industrial Engineering, Life Sciences, Chemistry, or a related technical discipline required.
  • Experience with sterile products, injectable products, and/or combination products preferred.
  • Experience with packaging validation, qualification protocols, change control, and lifecycle management activities.
  • Proficiency in Microsoft Office applications and ERP systems (e.g., SAP).

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.
  • 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.

Compensation

  • Pay range (Based on Experience)

Benefits

  • 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
  • Education/Experience:

Company info

  • 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.
  • Our team of professionals collaborates tirelessly to pioneer advancements in manufacturing, distribution, and quality control, ensuring a holistic approach to healthcare.
  • 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.
  • to make a meaningful difference in people's lives by delivering high-quality, affordable medications while upholding the highest standards of integrity and excellence.
  • 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.

Equal opportunity

  • 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.

Visa & Work Authorization

  • iduals 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 s
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