Computer System Validation (CSV) Specialist at CAI

Sydney, New South Wales, Australia

Apply Now

Not SpecifiedCompensation

Mid-level (3 to 4 years), Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Pharmaceutical, Medical Device, BiotechnologyIndustries

Requirements

3+ years’ experience in CSV in pharma, biotech, or medical devices
Strong knowledge of GAMP 5, data integrity, and relevant regulatory frameworks
Experience validating ERP, LIMS, QMS, or equipment-related software
Detail-oriented, analytical, and proactive team player
Comfortable working flexibly to meet production schedules

Responsibilities

Lead validation activities (IQ/OQ/PQ) across GxP-regulated systems
Ensure compliance with FDA 21 CFR Part 11, EU Annex 11, GAMP 5
Partner with IT, QC, and business teams to meet user and regulatory needs
Author and review validation plans, risk assessments, and traceability matrices
Contribute to data integrity programs and support audits
Train staff and promote a quality-focused culture

Skills

Key technologies and capabilities for this role

Computer System ValidationCSVCommissioningQualificationValidationGxP

Questions & Answers

Common questions about this position

What experience is required for the CSV Specialist role?

Candidates need 3+ years’ experience in CSV in pharma, biotech, or medical devices, strong knowledge of GAMP 5, data integrity, and relevant regulatory frameworks, plus experience validating ERP, LIMS, QMS, or equipment-related software.

Where is the work location for this position?

The role is based in Sydney, Australia, at a cutting-edge advanced therapeutics facility.

What is the company culture like at CAI?

CAI emphasizes employee ownership, foundational principles like acting with integrity, serving each other and society, and working for the future, with a collaborative culture focused on team success, respect, and professional growth through certifications and training.

What are the key responsibilities of the CSV Specialist?

The role involves leading validation activities (IQ/OQ/PQ) across GxP-regulated systems and ensuring compliance in a high-growth environment.

What makes a strong candidate for this CSV Specialist position?

A strong candidate is detail-oriented, analytical, proactive, a team player comfortable working flexibly, with hands-on CSV experience in GxP environments in pharma, biotech, or medical devices.

CAI

Consulting for operational readiness in healthcare

About CAI

CAI Technical Consulting Malaysia SDN, under the brand cagents.com, offers consulting services focused on operational readiness for clients in the pharmaceutical, biotechnology, and healthcare sectors. They conduct operational readiness assessments to evaluate a company's preparedness and tailor their services accordingly, which include project planning and asset management. CAI stands out from competitors by emphasizing professional development and industry collaboration, ensuring their team stays updated on industry trends. Their goal is to help clients achieve operational excellence and readiness for full-scale production.

Overland Park, KansasHeadquarters

1996Year Founded

$3.4MTotal Funding

PRE_SEEDCompany Stage

Industrial & Manufacturing, Biotechnology, HealthcareIndustries

1-10Employees

Benefits

100% Employee Owned

24 Days PTO/5 Sick days per year + Additional Holidays depending on Country

Medical / Dental / Vision (In accordance with each countries’ applicable regulations)

Professional Development (Approximately $5,000 paid career-related, continuing education)

ESOP/401k – 15% Company Contribution

Company Paid Long-Term Disability

Company Paid Life Insurance

Company Paid Parental Leave (In accordance with each countries’ applicable regulations)

Other Benefits Depending on Country

Risks

Competition from specialized firms in digital transformation may erode CAI's market share.

In-house consulting teams in corporations could reduce demand for CAI's services.

Remote work models decrease demand for traditional on-site consulting, impacting CAI's operations.

Differentiation

CAI offers comprehensive consulting services across multiple industries, including life sciences.

Their expertise in energy management aligns with the sustainability focus of data centers.

CAI's risk management services cater to the growing cybersecurity needs in process manufacturing.

Upsides

Demand for digital transformation in life sciences boosts CAI's automation consulting services.

Personalized medicine trends create opportunities for flexible manufacturing process consulting.

Data centers' focus on energy efficiency aligns with CAI's energy management expertise.

Land your dream remote job 3x faster with AI

Try Jobo Free