About the role

Aplyr's Quick Take

This role is for a Validation Engineer focused on developing documentation and executing protocols for the commissioning and validation of pharmaceutical facilities and equipment. It's an individual contributor role that involves hands-on work at client sites, particularly in FDA-regulated environments.

Good fit

Candidates with 4+ years of experience in validation within the pharmaceutical or biotech industries will thrive here. A proactive, team-oriented attitude and a background in engineering or relevant sciences are essential.

Worth noting

The company is 100% employee-owned, which may appeal to those looking for a collaborative and invested workplace culture. The role offers exposure to cutting-edge technologies and the opportunity for professional development through certifications and training.

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.

About CAI:

CAI is a 100% employee-owned company established in 1996, it has grown year over year to over 850 people worldwide. We provide commissioning, qualification, validation, start-up, project management and consulting services related to operational readiness to FDA regulated and other mission critical industries.

Are You Ready?

Our approach is simple; we put the client’s interests first, we do not stop until it is right, and we will do whatever it takes to get there.

As owners of 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.

With employee ownership, one person’s success is everyone’s success; we work diligently to accomplish team goals. We place Team Before Self, demonstrate Respect for Others, and possess a can-do attitude. That is how we have grown exponentially.

CAI agents (employees) will be exposed to cutting edge technologies in the advanced medicine space. You will have an opportunity to work with recognized subject matter experts allowing YOU to be a key player in bringing lifesaving therapies to market, including COVID19 Vaccines and therapies. As part of our company culture, we invest in YOUR future, and commit to hands on certifications as well as professional training. Our collaborative culture ensures that our customers benefit from exemplary work across our entire range of professional services.

Requirements include:

Position Description:

We are now seeking Validation Engineers to join our growing operations in Australia. The Validation Engineer develops documentation for the Commissioning, Qualification, and Validation of pharmaceutical facilities, utilities, and equipment. Our Engineers are responsible for protocol writing and execution (field verification), and development of summary reports at client sites.

Position Requirements:

BS or MS in a relevant science or engineering field, or equivalent years of hands-on experience

4+ years relevant experience commissioning/validating in an FDA regulated industry

Autoclave / Parts Washer Qualification experience is required

Experience in 1 or more of the following is desired: facilities and equipment startup, walk downs & troubleshooting, utilities (WFI, RO, HVAC), building automation or other pharmaceutical manufacturing processes and equipment, FAT/SAT, URS, design review, P&IDs, IQ/OQ/PQs, generation & execution, etc

Excellent technical problem-solving and troubleshooting skills

High attention to detail

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

Ability to work independently

Support onsite and offsite activities, such as: FATs, SATs, IOQ and PQ Executions and System Walkdowns

Other Requirements:

Expertise in Microsoft Word and Excel

Excellent oral and written English are required.

Able to travel domestically and internationally if required.

Able to work in Australia without sponsorship.

In return for your skills and knowledge, CAI offers a wide range of benefits including:

Highly Competitive Salary

Continuing education (internal and external)

Opportunities to work on cutting edge projects in a highly evolving field.

#LI-JW1

Skills & Tags

go ai design

Aplyr's read

CAI leverages cutting-edge AI and automation to streamline business processes, attracting skilled engineers and project managers in validation and commissioning roles.
Synthesized from recent postings & public sources

What's promising

•CAI focuses on AI-driven solutions, offering cutting-edge technology to enhance business efficiency.
•The company has a strong emphasis on hiring experienced engineers, indicating a commitment to technical excellence.
•CAI's involvement in data center projects highlights its role in critical infrastructure development.

What to watch

•Limited public information about CAI's financial stability and growth prospects.
•High concentration of roles in validation may limit opportunities for diverse career paths.
•Potential challenges in maintaining innovation pace in a rapidly evolving AI industry.

Why CAI

•CAI specializes in automation and AI, setting it apart in business process enhancement.
•The company is deeply involved in mission-critical data center projects, emphasizing its technical expertise.
•CAI's focus on validation and commissioning roles highlights its niche in quality assurance and project execution.

Aplyr’s read is generated by AI from public sources. Was it useful?

About CAI

CAI

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CAI is a company that specializes in providing advanced technology solutions, focusing on automation and artificial intelligence to enhance business processes.