---
title: 'QA Specialist at CAI'
canonical: 'https://feeny.ai/job/qa-specialist-cai-melbourne-mb52trv0j3r7'
type: 'job'
last_seen: '2026-09-16'
---

# QA Specialist at CAI

- **Company:** CAI
- **Location:** Melbourne, Australia
- **Employment:** contract
- **Work type:** onsite
- **Posted:** 2026-04-15
- **Last confirmed live:** 2026-09-16
- **Apply:** https://jobs.lever.co/cagents/807b5d85-f02d-4390-a7ce-5972b958a9c4

## Job description

CAI Overview Are You Ready? CAI is a professional services company established in 1996 that has grown year over year to nearly 800 people worldwide. For Life Sciences and Mission Critical industries that need to deliver critical solutions in high-stakes environments, we provide accelerated operational readiness and unparalleled performance at the highest standard through our rigorous approach, field-tested processes, and elite expertise developed over 30 years. Our approach is simple because our Purpose informs everything we do:

- We exist to be the trusted solution for our clients as they strive to build a better working world and improve the human experience. At CAI, we are committed to living our Foundational Principles, both professionally and personally:
- We act with integrity
- We serve each other
- We serve society
- We work for our future At CAI, we believe in a relentless dedication to excellence, pushing boundaries and surpassing expectations. From the beginning, we’ve challenged ourselves to do what others wouldn’t. Not just setting industry standards, but redefining them entirely. We are bold in our thinking and creative in our approach. We operate at the intersection of wisdom and technology and thrive when they come together with humanity. For us, operational readiness isn’t simply a goal. It’s a way of life. Because tomorrow demands to be at the forefront of today. We do this through tireless effort, precision, efficiency and an unwavering belief that there is always room for advancement. We’re not interested in how it used to be done. We’re obsessed with how it will be done.

Requirements include: Position Description: Validation: •Work closely with the Validation manger to ensure completion of validation goals and objectives.

- Support validation projects from initiation to completion, ensuring they are delivered on time and within budget. This requires coordinating with cross-functional teams and maintaining clear communication throughout the project lifecycle.
- Support the testing and validation of equipment, cleaning processes, analytical processes, and software.
- Support the development and implementation of validation plans, protocols, and procedures.
- Evaluate and approve validation plans, protocols, and reports to ensure completeness and accuracy.
- Within validation projects ensure that all aspects of validation, testing, and documentation are completed in a timely and efficient manner.
- Utilisation of effective risk management is crucial for maintaining product quality and compliance.
- Identify potential risks associated with validation processes and support the development of mitigation strategies.
- Conduct risk assessments to identify potential issues in products and processes.
- Establish and maintain validation procedures and processes that meet company policies and applicable regulations.
- Work to schedules for validation activities to ensure timely execution and completion.
- Participate in the tracking, reporting and trending validation activities and results.
- Ensure management is aware of validation department performance, trends in products/processes, and changes that could impact the facility.
- Track & trend processes to monitor validation department performance.
- Work closely with cross-functional teams to resolve validation issues and to ensure all products and processes are validated accurately and efficiently. Ensure validation activities are integrated into the overall project lifecycle.
- Support compilation and review of Product Quality Reviews/ Annual Product Reviews, as appropriate.
- Communicate with internal and external stakeholders regarding projects, products, and other validation related topics.
- Performs other job-related duties as assigned. Regulatory Compliance: •Responsible for compliance with relevant regulations, legislation, and standards.
- Support preparation efforts for regulatory inspections and audits related to validation activities.
- Support the Generation of audit responses to observations in a clear and wholistic manner
- Support company Data integrity program.
- Support the inspection readiness program.
- Knowledge of relevant TGA and regulatory guidelines to ensure cGMP compliance. Training and Development:
- Proactively foster an open, supportive, values-based culture, and work environment.
- Utilise a broad understanding of cGMP to provide Validation support, mentoring and coaching for Quality, Operations, Analytical, Logistics and Engineering departments to assure that activities are undertaken in compliance with cGMP and internal procedures, as appropriate. Other Duties:
- Identify continuous improvement opportunities and implement solutions to improve programs and meet business goals.
- Participating in Internal meetings/events/activities as required.

Requirement:

- A bachelor’s degree in a relevant field such as engineering, life sciences, or quality assurance is essential. Advanced degrees or certifications in validation or quality systems can be advantageous. Demonstrated experience in Validation in a relevant or related industry.
- A minimum of 2 years of experience in validation, quality assurance, or a related field is required.
- Strong understanding of FDA, EMA, and ISO regulations including PDA and ISPE pertinent to validation activities is crucial.
- Proficiency in validation management software such or similar tools is required. Experience with electronic documentation systems and risk management tools is also beneficial.
- Good project management skills are necessary for supporting validation projects effectively.
- Excellent analytical skills are required to assess validation data and identify trends.
- Familiarity with relevant technology and systems used in validation processes is necessary. This includes understanding software validation, equipment qualification, and process validation techniques
- The ability to adapt to changing regulations, technologies, and industry standards is crucial for success in this role.
- Good knowledge CGMP and GMP regulatory requirements nationally and internationally as required.
- Excellent attention to detail and decision making skills.
- Demonstrated knowledge and understanding of quality management principles, and a commitment to fostering a culture of quality and compliance.

## #LI-JD1

## About CAI

## Company Overview
- **One-liner**: CAI is a global professional services firm that accelerates operational readiness and excellence for life sciences and mission-critical facilities through commissioning, validation, engineering, and digital transformation expertise.
- **Entity Type**: Private (Privately Held; raised a venture round in May 2026)
- **Headquarters**: Indianapolis, Indiana, United States
- **Founded**: 1996
- **Founders**: Not publicly available

## Core Business
- **Primary industry/industries**: Life Sciences (pharmaceutical, biotech, medical device manufacturing) and Mission Critical (data centers, high-tech facilities)
- **Target customers**: B2B – enterprise-level pharmaceutical companies, biotech firms, data center operators, and regulated manufacturers
- **Mission or purpose statement**: “Making what’s next possible” by delivering precision, efficiency, and innovation through commissioning, qualification, validation, and operational readiness services.

## Products & Services
For each major offering:
- **Commissioning & Qualification (C&Q)**: End-to-end commissioning and qualification services for new and modified facilities, ensuring regulatory compliance and operational readiness.
- **Validation Services**: Computer Systems Validation (CSV), cleaning validation, process validation, and equipment validation for life sciences clients.
- **Automation & Digital Transformation**: Automation engineering, digital twin solutions, and technology integration to improve facility performance and data integrity.
- **Building Commissioning**: Mechanical, electrical, and plumbing commissioning for mission-critical buildings, including data centers and commercial facilities.
- **Human Performance & Operational Excellence**: Consulting and training programs to reduce human error, improve safety, and optimize asset management.
- **Project Management**: Owner’s project management and full-scale operations support for complex capital projects.

## Market Standing
- **Valuation/Market Cap**: Not disclosed (private)
- **Key Metric**: Annual Revenue of ~$10.2M (as of latest available data); Total Funding – venture round raised in May 2026 (amount undisclosed, 1 investor)
- **Notable Investors/Partners**: One venture investor (May 2026 round); strategic partnerships with technology vendors (unspecified) and participation in industry bodies such as ASHRAE, ASTM, BCA, and ISPE.
- **Growth Signals**: 
  - Employee headcount of 562, up 2.6% YoY
  - LinkedIn followers surged 72.3% over the past year, indicating strong brand interest
  - 84 active job postings globally
  - Offices in 5 countries (US, Ireland, Singapore, China, Australia) and operations across 21 countries
  - Clients include top pharma firms (Pfizer, Eli Lilly, MSD, Novartis, Thermo Fisher Scientific)

## Competitive Advantages
- **30 years of deep domain expertise** in highly regulated environments, giving CAI a track record that few competitors can match.
- **Elite, credentialed talent** – team members are active in nearly 30 professional societies and help set industry standards (ASHRAE, ISPE, ASTM, BCA).
- **Global footprint with local delivery** – ability to support multinational clients across the US, Europe, and Asia-Pacific.
- **End-to-end lifecycle support** – from commissioning and validation to digital transformation and operational excellence – reducing handoff risks.
- **Strong alumni pipeline to/from top pharma** – CAI attracts talent from Pfizer, Eli Lilly, Bristol Myers Squibb, and others, signaling deep industry credibility.

## Strategic Focus
- **Investing in Digital Transformation** – leveraging digital twin technology and automation to drive efficiency for clients.
- **Expanding Mission Critical Services** – actively hiring Data Center Commissioning Project Managers and Engineers in the US and Europe.
- **Sustainability Integration** – weaving green building practices (LEED, Net Zero Energy) into all client engagements.
- **Talent Development** – emphasizing top-tier training and career progression to retain high-knowledge employees.

## Why Work Here
- **Culture of teamwork and continuous improvement** – employee testimonials highlight a supportive team environment and commitment to process excellence.
- **Global, varied projects** – work on high-impact projects for leading pharma and data center clients across 21 countries.
- **Clear career growth** – career/professional development opportunities, exposure to multiple disciplines (validation, automation, commissioning, human performance).
- **Benefits package** – comprehensive health insurance, paid time off, competitive 401(k) contribution, income protection, and additional local-region benefits.
- **Remote/hybrid/office policy** – roles vary; many positions are client-site based (e.g., commissioning engineers travel to data centers or manufacturing sites). Some office locations available.
- **Engineering culture** – strong focus on quality, problem-solving, and precision; ideal for engineers, validation specialists, and project managers who thrive in regulated environments.

## Sources
1. [caiready.com](https://caiready.com/) – Company homepage and about page
2. [caiready.com/about](https://caiready.com/about/) – Company history and mission
3. [caiready.com/careers](https://caiready.com/careers/) – Careers page with benefits and culture
4. [linkedin.com/company/caiconnected](https://linkedin.com/company/caiconnected) – LinkedIn company profile and employee data
5. [jobs.lever.co/cagents](https://jobs.lever.co/cagents) – Active job postings

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