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Validation and Qualification Engineer

3 weeks ago

Limerick, Limerick, Ireland CAI Full time

About Us:

CAI is an employee-owned company established in 1996 with operations in Ireland and worldwide. We specialize in providing commissioning, qualification, validation, start-up, project management, and consulting services to FDA regulated and other mission critical industries.

Our Mission

We strive to deliver unparalleled service and expertise to our clients, ensuring that their goals are met and exceeded. Our team of experts works diligently to ensure that our clients receive the highest level of quality and service.

We live by our Foundational Principles:

  • We act with integrity
  • We serve each other
  • We serve society
  • We work for our future

We believe in teamwork and collaboration, working together to achieve common goals.

As part of our company culture, we invest in your future, providing opportunities for growth and development. Our collaborative culture ensures that our customers benefit from exemplary work across our entire range of professional services.

Job Responsibilities

We are seeking a CQV Engineer to join our team. The role of a CQV Engineer in CAI involves:

  • Conducting and leading Commissioning, Qualification, Validation team activities with a focus on Safety
  • Managing the C&Q documentation and execution lifecycle from SLIA generation through to OQ completion
  • Generating C&Q Procedures for projects
  • Approving project plans
  • Facilitating scoping/planning of commissioning spares and consumables
  • Delivering 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
  • Coordinating with project contractors and equipment vendors
  • Allocating project resources for efficient execution of project deliverables
  • Providing support during C&Q execution
Requirements
  • BS or MS in a relevant science or engineering field, or equivalent
  • 3+ years of experience in CQV SME roles for life sciences - Clean Utilities/Filling experience preferable
  • Excellent communication and problem-solving skills
  • Customer-service focused
  • Proficient in life science manufacturing processes
  • Able to travel domestically and internationally if required