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Senior Quality Control Engineer
1 week ago
Senior Quality Control/Validation Engineer IRELAND, IRELAND / NORTH EUROPE / FULL TIME About CAI: 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.
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, 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 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.
As a Senior team member, you will provide leadership and expertise in ensuring the highest standards of quality control are maintained throughout all equipment qualification activities.
Key Responsibilities: Lead and support Quality Control compliance for all equipment qualification activities, ensuring strict adherence to safety and regulatory standards.
Oversee and execute 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.
Lead 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.
Prepare, review, and maintain Qualification Summary Reports (QSRs) and related documentation to verify quality compliance.
Act as a key participant in Design Evaluations, Factory Acceptance Testing (FAT), Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ), ensuring high-quality outcomes.
Manage and oversee all quality control processes related to equipment qualification, including documentation control, change controls, and punch list tracking.
Collaborate with project contractors and equipment vendors, ensuring all tests are thoroughly performed and quality control standards are upheld.
Provide guidance and support for quality assurance tasks throughout the equipment qualification process to ensure consistent quality standards are upheld.
Position 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.
Skills: Quality Control QC Technican Equipment Validation Life Science Bio-Pharma Pharmaceutical Manufacturing Benefits: Pension Fund Medical Aid / Health Care Dental Care Income Protection Group Life Assurance
