Senior Validation Engineer — Sterile Pharma (Sacramento)

Nivagen Pharmaceuticals; Sacramento (CA); On-site; USD 120,000 - 150,000; Full time

Benefits offered by this job

Yearly bonus

Medical insurance

Dental insurance

Vision insurance

Paid time off

Job summary

Nivagen Pharmaceuticals is seeking a Sr. Validation Engineer to lead validation of processes, equipment, utilities, and systems for sterile pharmaceutical production in the Quality Assurance group.

You will develop scientifically justified validation approaches meeting cGMP and regulatory requirements, manage lifecycle projects, and mentor engineers. Reporting to the Director of Validation, you will review validation deliverables, ensure data integrity, and drive continuous improvement of

Qualifications

• Bachelor's degree or diploma in pharmaceutical sciences, engineering, life sciences, or a related technical field.
• Minimum five years of pharmaceutical validation experience, including sterile manufacturing.
• Strong working knowledge of cGMP, FDA/EMA requirements, ISO standards, validation lifecycle, and data integrity.
• Demonstrated experience leading equipment qualification and process validation projects, including protocol development and reporting.
• Experience with deviations, change controls, and supporting audits/inspections; cleaning validation experience is a plus.

Responsibilities

• Lead IQ/OQ/PQ for new and existing equipment and systems in sterile pharmaceutical production.
• Define qualification scope, test methods, acceptance criteria, and worst-case conditions.
• Develop and review validation plans, URs, risk assessments, protocols, and final reports.
• Coordinate process validation activities and support aseptic simulations with cross-functional teams.
• Mentor engineers, review documentation, and support audits/inspections.

Skills

Technical writing

Analytical skills

Troubleshooting

MS Word

MS Excel

Validation data systems

Aseptic processing

Sterile manufacturing

Education

Bachelor's degree or diploma in pharmaceutical sciences, engineering, life sciences, or related technical field

Tools

Kaye validation systems

Data loggers

Calibration instruments

Job description

Nivagen Pharmaceuticals is seeking a Sr. Validation Engineer to lead validation of processes, equipment, utilities, and systems for sterile pharmaceutical production in the Quality Assurance group.

You will develop scientifically justified validation approaches meeting cGMP and regulatory requirements, manage lifecycle projects, and mentor engineers. Reporting to the Director of Validation, you will review validation deliverables, ensure data integrity, and drive continuous improvement of