Senior Validation Engineer
Miejsce pracy: Dublin
Your 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.
Our requirements
* Bachelor's or master's degree in a relevant science or engineering field, or equivalent experience.
* 5+ years of industry-related experience in validation, quality control, or commissioning within pharmaceutical, biotech, or life sciences industries.
* Must have advanced English skills at least at a C1 Cambridge level
* 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 relocate to Ireland.
What we offer
Why CAI?
At CAI, we foster an environment of professional growth, collaboration, and hands-on learning. As CAI is a consulting company, you will be part of a team that values integrity, innovation, and long-term success. If you are a motivated professional with a passion for validation engineering, we encourage you to apply.
Join us and shape the future of quality and validation in the life sciences industry
Are You Ready – For an exciting new career?
Our approach is simple: we put the client's 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
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 professionals are 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 Engineers to join our growing operations throughout Europe. In particular, we have open vacancies across Ireland, Germany, Italy and the Netherlands. This role is designed for individuals with 5+ years of relevant experience in validation engineering who are looking to relocate and advance their careers in a dynamic, high-growth environment.
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.
Relocation Support
At CAI, we offer a comprehensive relocation package to ensure a smooth transition to your new country. This includes financial assistance, temporary accommodation, and travel support. Our team will guide you every step of the way to make your move as seamless as possible
Commissioning Agents (CAI)
Cześć Are you a skilled Validation Engineer based in Poland and looking for an opportunity to relocate? We are seeking experienced professionals ready to take the next step in their careers by moving to Ireland to work on cutting-edge biopharmaceutical projects.
CAI is a consulting 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.