CAI is a 100% employee-owned company established in 1996, that has grown year over year to more than 600 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 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. 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.
The Project Manager work with project teams at client sites to inspect, test, and troubleshoot bio-pharma manufacturing, packaging, and utility systems and equipment. This person is responsible for identifying and coordinating activities for commissioning and qualification and creating engineering and qualification protocols and reports. They will also manage the resources (people and budget) for same. The Project Manager will interact with client (Bio-pharma companies) personnel and the Regional Manager. The Project Manager will execute the work as well as oversee it. Aseptic manufacturing experience is highly desired.
BS in a science or engineering field or equivalent experience
5-7+ years’ experience commissioning and qualifying bio-pharmaceutical facilities, systems, and equipment, with project management experience highly preferred.
Experience with developing user requirements, design specifications, process/product risk assessments, validation requirements, development of testing protocols and test plans, and overall experience with the validation lifecycle is required. Experience with CIP/SIP, and aseptic manufacturing is desired
Excellent oral and written communication skills in English
Able to travel domestically and internationally if required
Able to work (paid) overtime
Able to work in the US without sponsorship now or any time or in the future.