Overview
Junior to Mid-Level Quality Control/Validation Engineer
IRELAND, IRELAND / NORTH EUROPE / FULL TIME
CAI is a 100% employee-owned company established in ****, 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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