Senior Validation Engineer (CSV) – On Site

Lonza; Vacaville, Northern (CA, KY); Hybrid; USD 93,000 - 155,000; Full time

Benefits offered by this job

Performance-related bonus

Medical, dental and vision insurance

401(k) matching plan

Life insurance

Short-term and long-term disability

Employee assistance programs

Paid Time Off

Job summary

Lonza is seeking a Senior Validation Engineer - CSV for a fully site-based role in Vacaville, focused on leading validation for manufacturing processes, equipment, and computerized systems to ensure regulatory compliance and quality.

This role requires strong cGMP knowledge and a proven track record in pharmaceutical/biotech manufacturing, with oversight of commissioning and qualification activities and cross-team coordination.

Qualifications

• Bachelor's degree in Engineering or related field and significant validation work experience.
• 5–8 years of validation experience in pharma/biotech/medical devices.
• Extensive knowledge of cGMP, FDA, EMA and related requirements.
• Experience validating Process Automation, DCS, MCS, PLCs, BAS and manufacturing equipment.

Responsibilities

• Oversee commissioning and qualification of equipment, utility systems, automation, and site computerized systems.
• Apply risk management to drive validation testing and decisions.
• Create, review and approve validation master plans, protocols and reports (DQ/IQ/OQ/PQ).
• Lead validation projects and coordinate across Engineering, MSAT, Manufacturing and Quality teams.
• Support audits with documentation and technical explanations.

Skills

Technical leadership

Risk-based validation

Regulatory knowledge

Verbal communication

Education

Bachelor's degree in Engineering

Tools

DCS

MCS

PLC

BAS

NetApp

Job description

Lonza is seeking a Senior Validation Engineer - CSV for a fully site-based role in Vacaville, focused on leading validation for manufacturing processes, equipment, and computerized systems to ensure regulatory compliance and quality.

This role requires strong cGMP knowledge and a proven track record in pharmaceutical/biotech manufacturing, with oversight of commissioning and qualification activities and cross-team coordination.