Senior Validation Engineer, CSV – Pharma Systems Lead

Lonza Group Ltd.; Vacaville (CA); On-site; Confidential; Full time

Benefits offered by this job

Performance-related bonus

Medical, dental and vision insurance

401(k) matching plan

Life insurance, plus short-term and长期注

Employee assistance programs

Paid Time Off

Job summary

Lonza Vacaville is seeking a Senior Validation Engineer - CSV in Vacaville, California, a fully site-based role that supports close, real-time collaboration and the high-precision manufacturing of medicines in a regulated environment.

The role leads validation of processes, equipment, and computerized systems with strong cGMP, FDA, EMA knowledge; you will drive risk-based validation and coordinate cross-functional teams across Engineering, MSAT, Manufacturing, and Quality.

Qualifications

• Bachelor's degree in Engineering or Life Sciences, or equivalent experience.
• 5–8 years in validation within pharma/biotech/medical devices.
• Extensive knowledge of cGMP, FDA, EMA regulations.
• Experience validating Process Automation Systems and PLCs.
• Strong writing and communication skills.

Responsibilities

• Oversee and perform commissioning and qualification of equipment, utilities, and automation systems.
• Apply risk-based validation testing and decision making.
• Create and approve validation masters, protocols, reports, deviations, and change controls.
• Develop and review DQ/IQ/OQ/PQ for new or modified equipment and processes.
• Peer review protocols and reports; track schedules and escalate delays.
• Provide technical leadership across Engineering, MSAT, Manufacturing, Quality.

Skills

Technical writing

Verbal communication

Interpersonal skills

Problem-solving

Leadership

Education

Bachelor's degree in Engineering / Life Sciences

Tools

DCS

MCS

PLC

BAS

Job description

Lonza Vacaville is seeking a Senior Validation Engineer - CSV in Vacaville, California, a fully site-based role that supports close, real-time collaboration and the high-precision manufacturing of medicines in a regulated environment.

The role leads validation of processes, equipment, and computerized systems with strong cGMP, FDA, EMA knowledge; you will drive risk-based validation and coordinate cross-functional teams across Engineering, MSAT, Manufacturing, and Quality.