CSV Lead

Ireland, Ireland  /  North Europe  /  Full Time

About CAI:
CAI is a 100% employee-owned company established in 1996, that has grown year over year to nearly 830 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.
Requirements include:
We are now seeking CSV Lead to join our growing operations in Ireland. The role of a CSV Lead in CAI is to:
·        Oversee and execute the Computer System Validation processes to ensure compliance with regulatory standards and company policies.
·        Create, review, and approve validation documentation, including Validation Master Plans (VMP), User Requirements Specifications (URS), Functional Requirements Specifications (FRS), and validation protocols (IQ/OQ/PQ).
·        Oversee and conduct Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) testing.
·        Deliver the CSV activities as required to meet the schedule.
·        Ensure all validation activities comply with applicable regulations (Annex 11)
·        Manage changes to validated systems, ensuring continued compliance and revalidation where necessary
·        Track progress of CSV activities as required.
·        Coordinate with project contractors and equipment vendors to execute required tests.
·        Allocate project resources for efficient execution of project deliverables.
Position Requirements:
·        A bachelor’s degree (BS/BA) in Engineering, Chemistry, or Life Sciences, with a minimum of 7+ years of related experience in the Pharmaceutical/Life Sciences industry. Relevant experience can substitute for education.
·        Essential experience in a GMP (Good Manufacturing Practice) environment.
·        Proficiency in validation software tools and methodologies
·        Outstanding oral and written communication skills.
·        Strong problem-solving abilities.
·        A strong customer-service focus.
·        Willingness and flexibility to travel throughout Europe and potentially internationally if required.



(Varies by Country, Below is a General Overview)

  • Comprehensive Health Insurance coverage aligned with local region regulations
  • Paid Time Off
  • ESOP/401K – 15% Company Contribution (US Only)
  • 15% Company Pension Contribution (Europe and APAC Regions)
  • Company Paid Life Assurance
  • Company Paid Income Protection/Long-Term Disability
  • Career/Professional Development Opportunities
  • Additional benefits/leave entitlements based on local regional requirements.
  • Other Benefits Depending on Country