CSV Engineer – GxP Pharma Validation

CAI; City of Brisbane; On-site; AUD 90,000 - 130,000; Full time

Benefits offered by this job

Highly competitive salary

Continuing education

Work on cutting edge projects

Job summary

CAI is seeking a CSV Engineer in Australia to develop and execute validation protocols and QMS documentation. You will identify gaps, coordinate with internal teams and external vendors, and ensure compliance with 21 CFR Part 11 and Annex 11.

Required: a BS in CS or Engineering and 2–7 years in CSV and GMP environments, with strong English communication and problem-solving skills. Travel domestically and internationally may be necessary.

Qualifications

• BS in Computer Science or Engineering or equivalent experience.
• 2–7 years’ experience with Computer Systems Validation (CSV).
• 2–7 years’ GMP environment experience.
• Experience with data integrity, GAMP, 21 CFR Part 11 highly desired.
• Pharma/biotech background preferred over medical devices.

Responsibilities

• Develop and execute validation protocols and test scripts.
• Prepare and review validation documentation for projects and changes.
• Manage change controls and non-conformances.
• Analyze test results and determine acceptability against criteria.
• Coordinate validation tasks with other departments and vendors.
• Support regulatory audits and communicate validation policies.

Skills

English proficiency

Communication skills

Problem solving

Team player

Willingness to travel

Education

Bachelor's in Computer Science or Engineering

Tools

MES

DeltaV

PI

Rockwell

Siemens

Honeywell

Job description

CAI is seeking a CSV Engineer in Australia to develop and execute validation protocols and QMS documentation. You will identify gaps, coordinate with internal teams and external vendors, and ensure compliance with 21 CFR Part 11 and Annex 11.

Required: a BS in CS or Engineering and 2–7 years in CSV and GMP environments, with strong English communication and problem-solving skills. Travel domestically and internationally may be necessary.