About CAI:
CAI is a 100 employeeowned company established in 1996 that has grown year over year to nearly 850 people worldwide. We provide commissioning qualification validation startup project management and consulting services related to operational readiness to FDA regulated and other mission critical industries.
Are you Ready
Our approach is simple; we put the clients 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 persons success is everyones success; we work diligently to accomplish team goals. We place Team Before Self demonstrate Respect for Others and possess a cando 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.
Requirements include:
We are now seeking Project (CQV) Engineers to join our growing operations in the UK. We are currently targeting Project (CQV) Engineers for roles in the London region. The role of a Project (CQV) Engineer in CAI is to:
Perform Commissioning Qualification Validation team activities with a direct regard for Safety.
Generating C&Q Procedures for projects.
CQV review/qualify equipment design filling line (IMA / Optima)
Writes reviews and revises a variety of Installation Operation and Performance qualification/verification related documents including any of all of the following: SOPs validation/verification master plans guidelines and plans
Facilitate scoping / planning of commissioning spares and consumables.
Deliver the C&Q activities as required to meet the schedule
Track progress of C&Q activities as required.
Preparation of Qualification Summary Reports (QSR) and management of Requirement Traceability Matrix (RTM)
of Design reviews shakedown commissioning FATs IQ OQ PQ activities.
Coordinate with project contractors and equipment vendors to execute required tests.
Allocate project resources for efficient of project deliverables.
Coordinate support during C&Q
Position Requirements:
BS or MS in a relevant science or engineering field or equivalent
5 years in CQV SME roles for life sciences prior filling line (IMA / Optima) experience is desirable
Excellent oral and written communication skills
Excellent problemsolving skills
Customerservice 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.