Deviation Author

Bloomington, Indiana  /  Midwest  /  Full Time

About CAI
CAI is a 100% employee-owned company established in 1996, that has grown year over year to over 700 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.
These are full-time W-2 opportunities with competitive compensation and benefits which include: Health insurance at very low cost to employee, 15% retirement contribution, and support for continued professional education.
Requirements include:
Position Description:  You will work with the manufacturing team of a biotechnology API manufacturing and filling/finish plant.  You will interface with the manufacturing team to understand root cause issues behind manufacturing deviations.  You will be able to communicate this in an organized fashion to both internal and external parties.  You will be comfortable interfacing with a variety of software applications to document root causes, changes and manufacturing deviations.
Position Requirements:
BS/BA in science/engineering
Experience in planning, task coordination and communication between multiple parties
Able to analyze manufacturing / technical problems to ascertain root causes
Excellent oral and written communication skills in English
Customer-service focused
Demonstrated success in ability to achieve defined goals.
Demonstrated skill in Microsoft Word, Excel, Powerpoint, formatting documents and presentations of data.
Excellent oral and written English is required
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



(Varies by Country, Below is a General Overview)

  • 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