Nivagen Pharmaceuticals, Inc. · 3 months ago
Validation Engineer - Pharmaceutical Sterile Manufacturing
Sacramento, CA 95834
Full-time
Onsite
Entry, Mid Level
2+ years expNivagen Pharmaceuticals is a global company focused on developing cost-effective generic prescription drugs and over-the-counter products for the North American market. The Validation Engineer will be responsible for ensuring that manufacturing processes and systems in the sterile pharmaceutical production environment comply with regulatory requirements and industry standards. This role involves managing the validation lifecycle and collaborating with cross-functional teams to optimize manufacturing processes.
ManufacturingMarket ResearchPharmaceutical
Responsibilities
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
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
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
Perform any additional tasks as assigned by the Validations Lead
Qualification
Required
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 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 willing to move to Sacramento Metropolitan Region (Approx. 40 miles' radius)
Willing to travel as needed basis to other manufacturing sites for vendor support
Preferred
Knowledge of cleaning validation will be an added advantage
Benefits
Competitive salary
Yearly bonus eligibility
Medical, dental and vision coverage
Paid time off plan
401k 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
Bizjournals.com Feed (2025-11-12 15:43:17)
2026-01-07
2025-05-23
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