Validation Engineer
vor 1 Monat
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.
Meeting a Higher Standard
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.
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.
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).
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