Validation Engineer - Pharmaceutical Sterile Manufacturing

Validation Engineer - Pharmaceutical Sterile Manufacturing

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.

3900 Duckhorn Dr, Sacramento, CA 95834

Title of the Position:
Validation Engineer

At Nivagen as a Validation Engineer you will be responsible for ensuring that manufacturing processes, equipment, utilities, and systems in the sterile pharmaceutical production environment meet all regulatory requirements, industry standards, and company specifications.

The role involves independently working and supporting the validation lifecycle from installation through qualification and routine re‑validation activities, ensuring that the company's sterile manufacturing processes are in compliance with cGMP (current Good Manufacturing Practices) and other regulatory guidelines such as FDA, EMA, and ISO standards.

• Qualification of Equipment and Systems:
• Perform or oversee the Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) of new and existing equipment and systems.
• Qualification of equipment in sterile manufacturing facility (e.g., aseptic processing, sterile filling, isolators, autoclave sterilization).
• Ensure compliance with regulatory requirements for equipment qualification and validation.
• Knowledge of validation equipment like Kaye validator, temperature and RH data loggers etc.
• Validation Documentation and Protocols:
• Prepare and review validation reports to ensure they meet regulatory and company requirements.
• Maintain traceability of validation activities and ensure all validation records are accurately documented, maintained, and stored.
• Process Validation and Cleaning Validation:
• Conduct and manage process validation studies to confirm the sterility and quality of pharmaceutical products.
• Work with cross‑functional teams (e.g., production, quality control, engineering) to optimize manufacturing processes and ensure consistency and repeatability.
• Support the development and implementation of new processes, ensuring that they are validated per regulatory requirements.
• Knowledge of cleaning validation will be an added advantage.
• Perform any additional tasks as assigned by the Validations Lead

• Bachelor's degree or Diploma in Pharmaceuticals, or a related field.
• Minimum 2 years of experience in a pharmaceutical manufacturing or validation role, with a focus on sterile manufacturing (e.g., aseptic processing, sterile filling, isolator, autoclave sterilization).
• Strong understanding of cGMP, FDA, EMA, ISO standards, and other relevant regulatory requirements.
• Experience with equipment validation (e.g., filling machines, autoclaves, and HVAC systems) and process validation.
• Familiarity with the documentation requirements for validation, including protocol development, execution, and report writing.

• Excellent technical writing and documentation skills.
• Strong attention to detail and ability to manage…