Senior Validation Engineer: CSV & Lifecycle Expert

AstraZeneca; Redwood City (CA); On-site; USD 102,000 - 152,000; Full time

Benefits offered by this job

Bonus incentives

Equity awards

Retirement plan

Health insurance

Paid time off

Job summary

AstraZeneca in Redwood City seeks a validation specialist to qualify and validate equipment, processes, products, and facilities to support site goals and targets. You will prepare qualification and process validation protocols, analyze data, and compile final reports in line with regulations and AZ policies.

The role may include supervising junior staff and contract personnel while ensuring cGMP compliance.

Qualifications

• BS degree in relevant discipline required.
• 3+ years in independent development, writing and performance qualifications/validation.
• Strong analytical skills and attention to detail; able to document deviations and investigations.

Responsibilities

• Qualify/validate equipment, processes, products, and facilities per approved protocols.
• Prepare qualification, requalification, and process validation reports in compliance with regulations and AZ policies.
• Provide supervision and training for validation personnel and contractors.

Skills

Validation

Quality systems

cGMP

Data analysis

Technical writing

Project coordination

Regulatory compliance

Training

Education

BS degree in relevant discipline

Master’s/PhD in engineering/science or related field

Tools

URS, PID, DQ, IQ, OQ, PQ

Digital tools for reporting

Job description

AstraZeneca in Redwood City seeks a validation specialist to qualify and validate equipment, processes, products, and facilities to support site goals and targets. You will prepare qualification and process validation protocols, analyze data, and compile final reports in line with regulations and AZ policies.

The role may include supervising junior staff and contract personnel while ensuring cGMP compliance.