QC/Validation Engineer at CAI – Limerick, New York

About CAI:

CAI is a 100% employee-owned company established in 1996, that has grown year over year to nearly 700 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.

Are You Ready?:

Our approach is simple; we put the clients 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 persons success is everyones 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.

We are now seeking a Quality Control Technician to join our growing operations in Ireland. In this QC-focused role at CAI, the QC Technician will:

- Support Quality Control compliance throughout all equipment qualification activities, ensuring safety and regulatory standards are met.

- Assist in the documentation and execution of equipment qualification processes, from initial assessments through to Operational Qualification (OQ), with an emphasis on accuracy and quality.

- Follow established procedures and protocols for new equipment qualification to embed quality practices within workflows.

- Review and complete Test Outlines and Procedures (TOPs) to verify alignment with quality specifications.

- Help plan and organize commissioning materials and consumables, ensuring they meet quality requirements.

- Monitor equipment qualification activities to ensure timelines are met without compromising quality standards.

- Prepare and maintain Qualification Summary Reports (QSRs) and related documentation to confirm adherence to quality standards.

- Participate in equipment Design Evaluations, Factory Acceptance Testing (FAT), Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ), maintaining a focus on quality outcomes.

- Manage quality control processes related to equipment qualifications, including documentation control, change controls, and punch list tracking.

- Work closely with project contractors and equipment vendors to perform and verify tests, ensuring strict quality control is maintained.

- Support quality assurance tasks throughout the equipment qualification process to ensure consistent quality standards are upheld.

- BS or MS in a relevant science or engineering field, or equivalent experience.

- 3+ years of industry related experience

- 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.