About CAI
We are a 100% employee-owned company established in 1996, with nearly 700 employees worldwide. We provide commissioning, qualification, validation, start-up, project management, and consulting services related to operational readiness in FDA regulated and other mission-critical industries.
Our Approach
We put our clients' interests first, and we do not stop until it is right. As owners of CAI, we are committed to living our Foundational Principles, both professionally and personally:
* Act with integrity
* Serve each other
* Serve society
* Work for our future
Job Overview
We are seeking a Senior Validation Engineer to join our growing operations in Ireland. This role is specifically designed for individuals with 7+ years of relevant experience in Validation Engineering.
Key Responsibilities
* Lead and support Quality Control compliance for all equipment qualification activities, ensuring strict adherence to safety and regulatory standards
* Oversight and execution of equipment qualification processes from initial assessments to Operational Qualification (OQ), ensuring accuracy, consistency, and adherence to quality standards
* Mentor and guide junior team members in implementing best practices for equipment qualification and quality control
* Review and complete Test Outlines and Procedures (TOPs), ensuring they align with established quality specifications and regulatory requirements
* Leadership in the planning and organization of commissioning materials and consumables, verifying they meet required quality standards
* Ensure that equipment qualification activities progress according to established timelines without compromising quality
* Preparation, review, and maintenance of Qualification Summary Reports (QSRs) and related documentation to verify quality compliance
* Participation in Design Evaluations, Factory Acceptance Testing (FAT), Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ), ensuring high-quality outcomes
* Management and oversight of all quality control processes related to equipment qualification, including documentation control, change controls, and punch list tracking
* Collaboration with project contractors and equipment vendors, ensuring all tests are thoroughly performed and quality control standards are upheld
* Guidance and support for quality assurance tasks throughout the equipment qualification process to ensure consistent quality standards are upheld
Requirements
* BS or MS in a relevant science or engineering field, or equivalent experience
* 7+ years of industry-related experience in a similar role
* Strong oral and written communication skills, with a focus on clear documentation and reporting
* Excellent problem-solving skills with a Quality Control mindset
* Strong customer-service orientation
* Proficient in life science manufacturing processes such as biotech, aseptic fill/finish, oral solid dose (OSD), and gene therapy, or with equivalent experience
* Willing and able to travel domestically and internationally, if required