CAI is a 100% employee-owned company established in 1996, that 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 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.
We are now seeking HVAC CQV Lead to join our growing operations in Ireland. The role of a HVAC CQV Lead in CAI is to:
· Lead/mentor a C&Q team ensuring C&Q deliverables are generated/executed in accordance with GMP practices and site procedures,
· Experience in the Commissioning of Cleanroom HVAC systems and the Qualification of Grade C & D environments within GMP facilities.
· Work in an integrated team environment,
· Provide input to master schedule on C&Q deliverables,
· Review and approve of technical design documents,
· Review and approve of C&Q documents,
· Review and approve of CTOP’s and VTOP’s,
· Participate in the generation of C&Q documents,
· Coordinate C&Q test execution,
· Coordinate vendor site visits for SAT testing,
· Witness vendor commissioning activities,
· Own HVAC C&Q deliverables throughout C&Q phase,
· Report daily on C&Q progress,
· A degree in Building Services, Mechanical Engineering or related discipline is preferable.
· 7+ years in CQV HVAC SME roles for life sciences
· Excellent oral and written communication skills
· Excellent problem-solving skills
· Customer-service focused.
· Proficient in life science manufacturing processes in areas such as biotech, aseptic fill/finish, OSD, Gene Therapy or equivalent experience.
· Able to travel domestically and internationally if required.