About CAI
CAI is a 100% employee-owned company established in 1996. We have grown year over year to nearly 700 people worldwide, providing commissioning, qualification, validation, start-up, project management and consulting services related to operational readiness for FDA regulated and other mission critical industries.
Meeting a Higher Standard
We put our clients' interests first, do not stop until it is right, and do whatever it takes to get there.
Our Foundational Principles
1. We act with integrity.
2. We serve each other.
3. We serve society.
4. We work for our future.
As owners of CAI, we live these principles both professionally and personally. With employee ownership, one person's success is everyone's success. We place Team Before Self, demonstrate Respect for Others, and possess a can-do attitude, which has enabled us to grow exponentially.
Career Opportunities
CAI agents will be exposed to cutting-edge technologies in the advanced medicine space. You will have the opportunity to work with recognized subject matter experts, enabling you to play a key role 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.
Job Requirements
We are now seeking a CQV Engineer to join our growing operations in Ireland. The role of a CQV Engineer in CAI is to:
1. Conduct and lead Commissioning, Qualification, Validation team activities with direct regard for Safety.
2. Manage the C&Q documentation and execution lifecycle from SLIA generation through to OQ completion.
3. Generate C&Q Procedures for projects.
4. Approve TOPs.
5. Facilitate scoping/planning of commissioning spares and consumables.
6. Deliver the C&Q activities as required to meet the schedule.
7. Track progress of C&Q activities as required.
8. Prepare Qualification Summary Reports (QSR), and manage Requirement Traceability Matrix (RTM).
9. Execute Design reviews, shakedown, commissioning, FAT's, IQ, OQ, PQ activities.
10. Manage any aspect of C & Q, verification as requested (i.e., Change Controls, Management of Contractors and Vendors, document control, punch list management).
11. Coordinate with project contractors and equipment vendors to execute required tests.
12. Allocate project resources for efficient execution of project deliverables.
13. Coordinate support during C&Q execution.
Position Requirements
1. Bachelor's or Master's degree in a relevant science or engineering field, or equivalent.
2. 3+ years in CQV SME roles for life sciences – Clean Utilities/Filling experience preferable.
3. Excellent oral and written communication skills.
4. Excellent problem-solving skills.
5. Customer-service focused.
6. Proficient in life science manufacturing processes in areas such as biotech, aseptic fill/finish, OSD, Gene Therapy or equivalent experience.
7. Able to travel domestically and internationally if required.
Equal Opportunities Employer
We are an equal opportunity employer, proud to employ veterans and promote a diverse culture 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.