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Validation Engineer - Pharmaceutical Sterile Manufacturing

Nivagen Pharmaceuticals LLCSacramento, CA 95834
On-site Full-time $90K/yr - $105K/yr

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Qualifications

Key Responsibilities: Equipment and Systems Qualification: Lead or supervise the Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) of both new and existing equipment and systems. Conduct equipment qualification in sterile manufacturing settings (e.g., aseptic processing, sterile filling, isolators, autoclave sterilization). Ensure all equipment qualification and validation activities comply with pertinent regulatory requirements. Manage the validation documentation process and ensure that all records are accurate and compliant with regulatory expectations. Collaborate with cross-functional teams to identify and rectify validation-related issues. Participate in audits and inspections, providing validation expertise and insights. Maintain up-to-date knowledge of industry trends and regulatory changes affecting validation processes.

About the job

About Nivagen Pharmaceuticals:

Nivagen Pharmaceuticals LLC is a leading global enterprise committed to improving health outcomes by delivering affordable generic prescription medications and over-the-counter products tailored for the North American market. For over ten years, we have remained dedicated to our core values of excellence, integrity, and respect for individuals. Our dedicated team tirelessly collaborates to drive innovations in manufacturing, distribution, and quality assurance, guaranteeing a comprehensive approach to healthcare. By leveraging vertical integration across the pharmaceutical supply chain, utilizing state-of-the-art technology, and maintaining a steadfast commitment to quality, we are continually working to enhance medication accessibility and affordability. We prioritize the well-being of our employees through competitive salaries, comprehensive benefits, and extensive training and development opportunities. At Nivagen, we strive to empower our workforce to foster innovation and make a positive impact in the healthcare sector. Our mission is to significantly improve lives by providing high-quality, cost-effective medications while adhering to the highest standards of integrity and excellence.

Job Overview:

As a Validation Engineer at Nivagen, your primary responsibility will be to ensure that our sterile pharmaceutical manufacturing processes, equipment, utilities, and systems comply with all regulatory standards, industry benchmarks, and internal specifications.

This role requires independent management and support of the validation lifecycle, from installation through qualification and routine re-validation activities, ensuring strict compliance with current Good Manufacturing Practices (cGMP) and other regulatory guidelines, including FDA, EMA, and ISO standards.

About Nivagen Pharmaceuticals LLC

Nivagen Pharmaceuticals LLC is a pioneering global company focused on enhancing healthcare through the development and provision of affordable generic prescription drugs and over-the-counter products. Our commitment to excellence and integrity drives our mission to improve medication access and affordability across North America.

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