Validation Engineer - Pharmaceutical Sterile Manufacturing

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: 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. **Responsibilities:** - **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** **Qualifications**: **Education/Experience:** - 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 **Knowledge, Skills, and Abilities:** - Excellent technical writing and documentation skills. - Strong attention to detail and ability to manage complex technical documentation. - Ability to work cross-functionally and manage multiple priorities. - Familiarity with data analysis tools and software used for validation testing and reporting (e.g., Excel, Validation Master Plans, LIMS systems). - Aseptic processing or sterile manufacturing practices. **Requirements:** - Must live or willing to move to Sacramento Metropolitan Region (Approx. 40 miles’ radius) - Willing to travel as needed basis to other manufacturing sites for vendor support **Work Environment:** - Cleanroom and sterile production areas with controlled environments. - Potential exposure to hazardous materials and chemicals used in pharmaceutical manufacturing processes. **Benefits:** - $90,000 to $105,000 - Yearly bonus eligibility - Benefits: Nivagen offers a wide variety of benefits and programs to support health and well-being - 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.