Validation Engineer - Pharmaceutical Sterile Manufacturing

Title:

Validation Engineer

Location:

Nivagen Pharmaceuticals, Sacramento, CA 95834

Ensure that manufacturing processes, equipment, utilities, and systems in the sterile pharmaceutical production environment meet all regulatory requirements and industry standards.

• Equipment and Systems Qualification
  • 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 (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.
• 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 (production, QC, 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 related field.
• Minimum 2 years of experience in a pharmaceutical manufacturing or validation role, focused on sterile manufacturing.
• Strong understanding of cGMP, FDA, EMA, ISO standards, and other relevant regulatory requirements.
• Experience with equipment validation (filling machines, autoclaves, 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 (Excel, Validation Master Plans, LIMS systems).
• Experience in aseptic processing or sterile manufacturing practices.

• Must live or be willing to move to Sacramento Metropolitan Region (approx. 40 miles radius).
• Willing to travel as needed to other manufacturing sites for vendor support.

• Cleanroom and sterile production areas with controlled environments.
• Potential exposure to hazardous materials and chemicals used in pharmaceutical manufacturing processes.

• Salary: $90,000 to $105,000.
• Yearly bonus eligibility.
• Medical, dental and vision coverage.
• Paid time off plan.
• 401k savings plan.

Nivagen provides 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 prohibits harassment or retaliation based on these factors.