Nivagen Pharmaceuticals, Inc. · 23 hours ago
Director of Validation
Sacramento, CA 95834
Full-time
Onsite
Director/Executive
10+ years expNivagen Pharmaceuticals is a global company dedicated to enhancing lives by developing and providing cost-effective generic prescription drugs. The Director of Validation is responsible for the strategic leadership, execution, and continuous improvement of all validation activities at a sterile pharmaceutical manufacturing site.
ManufacturingMarket ResearchPharmaceutical
Responsibilities
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
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
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
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
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
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
Qualification
Required
Bachelor's degree in engineering, Life Sciences, or related discipline
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
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
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
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
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
Preferred
Advanced degree (MS, PhD)
Benefits
Medical, dental, and vision coverage
Paid time off plan
401 (k) savings plan
Company
Nivagen Pharmaceuticals, Inc.
Nivagen is engaged in the development, acquisition and sales of generic prescription drugs and over the counter products for the North American market.
11-50 employees
H1B Sponsorship
Nivagen Pharmaceuticals, Inc. has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (19)
2024 (19)
2023 (15)
2022 (5)
2021 (11)
2020 (7)
Funding
Current Stage
Early StageTotal Funding
$31MKey Investors
Telegraph Hill Partners
2026-01-06Acquired
2023-08-09Series Unknown· $5M
2020-05-19Series Unknown· $16M
Recent News
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2026-01-07
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