Senior CQV Engineer

Switzerland  /  Europe/Ireland  /  Full Time

About CAI
CAI is a 100% employee-owned company established in 1996, it has grown year over year to nearly 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 (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:
We are now seeking a Senior CQV Engineer to join our growing operations in Switzerland. The role of a Senior CQV Engineer in CAI is to:
·       Develop documentation for the Commissioning, Qualification, and Validation of pharmaceutical facilities, utilities, and equipment.
·       Responsible for protocol writing and execution (field verification), and development of summary reports at client sites. Other responsibilities include planning / coordinating work and directing small teams in document development and / or execution.
Position Requirements:
·       BS or MS in a relevant science or engineering field, or equivalent years of hands-on experience
·       At least 10 years’ experience performing commissioning and / or qualification activities in an FDA regulated industry
·       Excellent technical problem-solving and troubleshooting skills, with solid knowledge of typical project technical issues
·       High attention to detail
·       Ability to multi-task and take initiative to accomplish assigned tasks accurately by established deadlines
·       Ability to work independently, while quickly building and nurturing a project team
·       Expertise in Microsoft Word and Excel
·       Familiarity with ISPE Baseline Guide 5 (Second Edition) a plus
·       Experience in planning / directing C&Q activities a plus
Other Requirements:
·       Excellent oral and written English are required. German and/or French is a plus.
·       Able to travel domestically and possibly internationally if required



(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