Director of Validation

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 Inc., Sacramento, CA

3900 Duckhorn Dr, Sacramento, CA 95834

About the Job:

Title of the Position: Director of Validation

The Director of Validation is responsible for the strategic leadership, execution, and continuous improvement of all validation activities at a sterile pharmaceutical manufacturing site. This role ensures that facilities, utilities, equipment, processes, cleaning, computerized systems, and aseptic operations are validated and maintained in a state of control in compliance with global regulatory requirements (FDA, EMA, ICH, and other applcable authorities).

The Director of Validation partners cross-functionally with Quality, Engineering, Manufacturing, Automation, IT, and Regulatory Affairs to support commercial manufacturing, new product introductions, site expansions, and regulatory inspections.

Responsibilities:

Validation Leadership & Strategy

• Develop and execute the site validation master plan (VMP) for sterile manufacturing operations


• Establish a validation strategy aligned with lifecycle validation principles and regulatory expectations


• Lead validation activities for new facilities, expansions, equipment, and technology transfers


• Ensure validation programs support aseptic processing, contamination control, and patient safety

Sterile Manufacturing & Technical Scope

• Oversee validation of:




• Aseptic processing and fill/finish operations


• Cleanrooms and controlled environments


• Utilities (WFI, clean steam, compressed gases, HVAC)


• Equipment (formulation vessels, autoclaves, washers, filling lines, Isolators, and RABs)


• Process validation (PQ, PPQ, CPV)


• Cleaning validation


• Computerized systems validation (CSV / CSA)




• Ensure compliance with Annex 1, FDA guidance, and current industry best practices

Compliance & Regulatory Support

• Ensure validation documentation meets GMP, data integrity, and inspection readiness standards


• Serve as validation SME during regulatory inspections and customer audits


• Address validation-related observations, CAPAs, and commitments


• Maintain inspection readiness through continuous improvement and metrics

Team Leadership & Development

• Lead, mentor, and develop a team of validation engineers and managers


• Set clear performance goals and promote a culture of quality, accountability, and collaboration


• Build scalable validation capabilities to support site growth and commercialization

Cross-Functional Collaboration

• Partner with Engineering on equipment qualification and commissioning strategies


• Collaborate with Quality Assurance on change control, deviations, and risk management


• Support Manufacturing and Technical Operations with troubleshooting and process improvements


• Align with Automation and IT on the computerized systems lifecycle management

Continuous Improvement

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  • Drive improvements in validation efficiency through risk-based approaches and digital tools
  
  
  • Implement best practices for commissioning and qualification (C&Q) and CPV
  
  
  • Monitor CQAs to ensure validation effectiveness and compliance
  
  
  
  

Qualifications:

Education

• Bachelor’s degree in engineering, Life Sciences, or related discipline (required)


• Advanced degree (MS, PhD) preferred

Experience

• 10+ years of experience in validation within GMP pharmaceutical manufacturing


• Minimum 5 years of leadership experience in sterile or aseptic manufacturing environments


• Proven experience supporting regulatory inspections (FDA, EMA)


• Experience with commercial manufacturing and late-stage or approved products

Technical Expertise

• Deep knowledge of sterile manufacturing validation and aseptic processing


• Strong understanding of FDA, EMA, ICH, and Annex 1 requirements


• Expertise in lifecycle validation, CPV, and risk-based validation approaches


• Familiarity with modern CSV/CSA methodologies

Leadership & Soft Skills

• Strong people leadership and organizational skills


• Excellent communication and stakeholder management abilities


• Ability to influence across functions and at senior leadership levels


• Strategic mindset with hands-on execution capability

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 be willing to move to the Sacramento Metropolitan Region (Approx. 40 miles’ radius)


• On-site presence required to support sterile manufacturing operations


• Occasional travel for audits, regulatory inspections, or corporate meetings

Work Environment:

• Cleanroom and sterile production areas with controlled environments.


• Potential exposure to hazardous materials and chemicals used in pharmaceutical manufacturing processes.

Benefits:

• Competitive salary


• 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


• 401 (k) 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.