About CAI
CAI is a 100% employee-owned company established in 1996, with nearly 700 people worldwide. We provide commissioning, qualification, validation, start-up, project management and consulting services to FDA regulated and other mission critical industries.
Meeting a Higher Standard
We put the client's interests first and do not stop until it is right. Our approach is guided by our Foundational Principles:
* We act with integrity.
* We serve each other.
* We serve society.
* We work for our future.
We are committed to living these principles both professionally and personally. As owners of CAI, one person's success is everyone's success; we work diligently to accomplish team goals.
Opportunities
You will be exposed to cutting edge technologies in the advanced medicine space, working with recognized subject matter experts to bring lifesaving therapies to market. We invest in your future, providing hands on certifications and professional training within a collaborative culture that ensures exemplary work across our range of professional services.
Job Requirements
We seek a CQV Engineer to join our operations in Ireland. The role involves:
* Leading Commissioning, Qualification, Validation activities with a direct regard for Safety.
* Approving TOPs.
* Facilitating scoping / planning of commissioning spares and consumables.
* Deliieving the C&Q activities as required to meet the schedule.
* Tracking progress of C&Q activities.
* Preparing Qualification Summary Reports (QSR), and managing Requirement Traceability Matrix (RTM).
* Executing Design reviews, shakedown, commissioning, FAT's, IQ, OQ, PQ activities.
* Managing any aspect of C & Q, verification as requested.
* Coordinating with project contractors and equipment vendors to execute required tests.
* Allocating project resources for efficient execution of project deliverables.
* Coordinating support during C&Q execution.
Position Requirements
To be considered, you must have:
* A BS or MS in a relevant science or engineering field, or equivalent.
* 3+ years in CQV SME roles for life sciences – Clean Utilities/Filling experience preferable.
* 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.
Diversity and Inclusion
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.