CSV Engineer

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

About CAI

CAI is looking for individuals with a range of experience in the areas of commissioning, qualification, and validation to join our team in Australia. Experience in the pharmaceutical, medical device or biotechnology industries is required.
CAI is a 100% employee‑owned company established in 1996 and has grown to more than 800 people worldwide. We provide commissioning, qualification, validation, start‑up, project management and consulting services related to operational readiness for FDA‑regulated and other mission‑critical industries.

Position Description

The Computer Systems Validation (CSV) Engineer will develop and execute protocols and test scripts, identify gaps, and consult on and direct plans for resolution. This person is responsible for writing GxP computer validation and 21 CFR Part 11 related documentation such as assessments, plans, URS, FRS, RTM, and summary reports.

Other duties may include:

• Prepares/reviews validation documentation related to projects/change controls.
• Manages change controls and other compliance related tasks e.g., non‑conformances.
• Participates in the review of current and future CSV procedures and policies.
• Analyzes the results of testing and determines the acceptability of results against predetermined criteria.
• Investigates and troubleshoots problems which occur and determines solutions or recommendations for changes and/or improvements.
• Identifies current and anticipated requirements for compliant computerized operations and suggests methods for the identification, implementation, and maintenance of the procedures, actions, and documentation necessary to ensure compliance within the operation.
• Coordinates with other departments or outside contractors/vendors to complete validation tasks.
• Participates in regulatory audits and communicates company’s computer validation policies.
• Assesses company’s computer systems and identifies any potential Part 11 or Annex 11 gaps.
• Manages projects and prepares status reports using Microsoft Project and other communication tools.
• May supervise, lead, or manage lower‑level personnel.

Position Requirements

BS in a Computer Science or Engineering field or equivalent experience.

Minimum 2–7 years’ experience with Computer Systems Validation.

Minimum 2–7 years’ experience in a GMP environment.

Experience in Data Integrity with GAMP and 483, compliance, deep 21 CFR Part 11 experience highly desired.

Experience in biotech and pharma is preferred over medical device.

Experience with MES, Delta V, PI is a plus. We use all major systems, including Rockwell, GE, Emerson, ABB, Werum, Siemens, Honeywell and others (e.g., PAS‑X, Syncade, FactoryTalk, PharmaSuite, Control Logix, PLM, Simatic, iFix, Wonderware).

Other Requirements

Excellent oral and written communication skills in English / fluent in English.

Able to travel domestically and internationally as required.

Excellent technical problem‑solving and troubleshooting skills, with solid knowledge of typical project technical issues.

High attention to detail.

Ability to multi‑task and take initiative to accomplish assigned tasks accurately by established deadlines.

Independent individual and yet a strong team player.

Benefits

• Highly Competitive Salary
• Continuing education (internal and external)
• Opportunities to work on cutting edge projects in a highly evolving field

Equal Opportunity Employer

We are an equal opportunity employer; we are proud to employ veterans and promote diversity and inclusion in our workplace. Diversity is a strength for our global company. We pledge that CAI will be operated in a way that is fair and equitable to all – our employees, our customers, and the broader society.

Additional Information

This job description is not all inclusive and you may be asked to do other duties. CAI will also consider for employment qualified applicants with criminal histories in a manner consistent with the requirements of the Fair Chance Act (FCA) / Fair Chance Ordinance (FCO).

We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses and identifying potential inconsistencies or verification signals in application materials based on available information. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.