Overview
Junior to Mid-Level Quality Control/Validation Engineer
IRELAND, IRELAND / NORTH EUROPE / FULL TIME
CAI is a 100% employee-owned company established in 1996, growing year over year to 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.
CAI agents will be exposed to cutting-edge technologies in the advanced medicine space, working alongside recognized subject matter experts. As part of our culture, we invest in YOUR future through hands-on certifications and professional training.
Position Overview
We are looking for a Junior to Mid-Level Validation Engineer to join our growing operations in Ireland. This role is designed for individuals with at least 2 years of relevant experience in Validation Engineering or Quality Control. As a Junior to Mid-Level Engineer, you will work alongside senior team members, assisting in maintaining quality standards and ensuring compliance throughout all equipment qualification activities.
Key Responsibilities
* Support and assist with Quality Control compliance for equipment qualification activities, ensuring adherence to safety and regulatory standards.
* Help document and execute equipment qualification processes, from initial assessments to Operational Qualification (OQ), focusing on accuracy and attention to detail.
* Follow established procedures and protocols for new equipment qualification to help embed quality practices within workflows.
* Assist with the review and completion of Test Outlines and Procedures (TOPs), verifying alignment with quality specifications.
* Support the planning and organization of commissioning materials and consumables, ensuring they meet required quality standards.
* Monitor equipment qualification activities to ensure that timelines are met while maintaining high quality standards.
* Assist in preparing and maintaining Qualification Summary Reports (QSRs) and related documentation to ensure compliance with quality standards.
* Participate in equipment Design Evaluations, Factory Acceptance Testing (FAT), Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ), with a focus on achieving quality outcomes.
* Assist in managing quality control processes related to equipment qualifications, including documentation control, change controls, and punch list tracking.
* Collaborate with project contractors and equipment vendors to perform and verify tests, ensuring quality control is upheld.
* Provide support for quality assurance tasks throughout the equipment qualification process, ensuring consistent quality standards are maintained.
Position Requirements
* BS or MS in a relevant science or engineering field, or equivalent experience.
* 2+ years of industry-related experience in a similar role.
* Strong oral and written communication skills, with a focus on clear documentation and reporting.
* Strong problem-solving skills with a focus on Quality Control.
* Customer-service oriented and able to collaborate well with internal teams and external vendors.
* Familiarity with life science manufacturing processes such as biotech, aseptic fill/finish, oral solid dose (OSD), and gene therapy, or equivalent experience.
* Willing and able to travel domestically and internationally, if required.
Skills
* Quality Control
* QC Technician
* Equipment Validation
* Life Science
* Bio-Pharma
* Pharmaceutical Manufacturing
Benefits
* Pension Fund
* Medical Aid / Health Care
* Dental Care
* Income Protection
* Group Life Assurance
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