Senior Validation Engineer – Sterile Drug QA Lead

nivagenpharmaceuticals; United States; On-site; USD 120,000 - 160,000; Full time

Benefits offered by this job

Competitive pay

Comprehensive benefits

Training & development

Job summary

Nivagen Pharmaceuticals in Sacramento, CA is seeking a Senior Validation Engineer to lead validation of processes, equipment, utilities, and systems in sterile pharmaceutical production. You will develop scientifically justified validation approaches that meet cGMP regulatory requirements and company procedures, manage projects through the validation lifecycle, and mentor engineers.

The role demands expertise in IQ/OQ/PQ, risk assessments, and robust documentation, with collaboration across

Qualifications

• Experience leading IQ/OQ/PQ protocols for new and existing equipment.
• Strong knowledge of cGMP regulatory requirements.
• Experience in sterile pharmaceutical manufacturing.
• Ability to mentor engineers and ensure technical accuracy.

Responsibilities

• Plan, write, execute, and review IQ/OQ/PQ protocols.
• Lead qualification of equipment, facilities, and utilities.
• Develop validation plans, risk assessments, and traceability matrices.
• Maintain validation records and support audits.
• Mentor validation engineers and coordinate with cross-functional teams.

Skills

Validation leadership

Quality systems

Regulatory compliance

Risk assessment

Documentation

Education

Bachelor's degree in Engineering or related field

Tools

Kaye validation systems

Job description

Nivagen Pharmaceuticals in Sacramento, CA is seeking a Senior Validation Engineer to lead validation of processes, equipment, utilities, and systems in sterile pharmaceutical production. You will develop scientifically justified validation approaches that meet cGMP regulatory requirements and company procedures, manage projects through the validation lifecycle, and mentor engineers.

The role demands expertise in IQ/OQ/PQ, risk assessments, and robust documentation, with collaboration across