About CAI
CAI is a 100% employee-owned company established in 1996. We provide commissioning, qualification, validation, start-up, project management and consulting services to FDA regulated and other mission critical industries worldwide.
Meeting a Higher Standard
We put the client's interests first and do not stop until it is right. We will do whatever it takes to achieve our goals.
Our Foundational Principles
1. We act with integrity
2. We serve each other
3. We serve society
4. We work for our future
We are committed to living our principles both professionally and personally.
CQV Engineer Role
We are seeking a CQV Engineer to join our team in Ireland. The role involves:
* Conducting and leading Commissioning, Qualification, Validation team activities with a focus on Safety
* Managing C&Q documentation and execution lifecycle from SLIA generation through to OQ completion
* Generating C&Q Procedures for projects
* Approving TOPs
* Facilitating scoping/planning of commissioning spares and consumables
* Delivering C&Q activities as required to meet the schedule
* Tracking progress of C&Q activities as required
* 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 i.e., Change Controls, Management of Contractors and Vendors, document control, punch list management
* 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
* 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
We are an equal opportunity employer. We promote a diverse culture in our workplace and pledge to operate in a way that is fair and equitable to all.