Catalyx is seeking a CSV Engineer to join our team and work on our customer site in Kerry.
Who We Are:
Catalyx isniest a machine vision and automation company that integrates technology and people to help global manufacturers and logistics companies achieve next‑generation levels of quality and throughput. For over thirty years, the minds behind Catalyx have been maximizing operational processes across highly regulated industries by inventing new technology applications and supporting companies with technical experts. With 9 global offices, over 550 team members, and 3,000 projects under our belt (and counting), we have the capabilities and reach to solve unique process problems at scale – and the vision to keep doing what’s never been done before.
The Role:
Catalyx is a trusted partner in delivering world‑class lifecycle services to regulated and high‑risk end markets. With a relentless commitment to innovation and excellence, we partner with life science and other highly regulated organisations to empower them to enhance efficiency and drive success. As part of this commitment, we are continuously developing our on‑site teams to support the advancement of customer operations.
The Computer Systems Validation (CSV) Engineer will be responsible for the planning, execution, and documentation of validation activities related to computer systems and software for use within a regulated environment (e.g., pharmaceutical, biotech, medical device, manufacturing). This role ensures compliance with regulatory requirements (FDA 21 CFR Part 11, GxP, EU Annex 11, etc.) and industry standards.
удаваResponsibilities:
1. Validation Planning & Execution:
Develop, review, and approve validation protocols, including IQ (Installation Qualification), OQ (Operational Qualification) and Acceptance Test ProtocolsPerform risk assessments to determineischen appropriate level of validation requiredCreate and execute validation test scripts to verify system functionality, data integrity, and compliance with regulationsEnsure that validation deliverables meet internal SOPs, industry standards, and regulatory requirements
2. Documentation & Reporting:
Create and maintain comprehensive validation documentation, including Validation Plans, Validation Summary Reports, and test resultsMaintain traceability matrices to ensure that all requirements are validated
3. Compliance & Regulatory Adherence:
Ensure that all computer systems and software used in regulated activities meet regulatory requirements, including FDA 21 CFR Part 11, EU Annex 11, and GAMP 5 guidelinesStay up to date with regulatory changes and industry best practicesEnsure proper electronic records and signatures are ininske where applicable
4. Cross‑functional Collaboration:
Work closely with software development, QA and project management teams to ensure that systems are validated in a timely mannerProvide guidance and training to team members on CSV‑related topics and best practicesAct as the CSV Subject Matter Expert (SME) during internal and external audits, including regulatory inspections
5. System Management & Support:
Support the lifecycle management of validated systems, including periodic reviews, revalidation, and system upgradesTrou تازه troubleshoot and resolve validation issues, ensuring that corrective and preventive actions (CAPAs) are implemented where necessaryempo oversee change control processes for validated systems to ensure ongoing compliance
6. Risk Management:
Conduct risk assessments for system validation projectsImplement mitigation strategies to reduce potential validation failuresEnsure ongoing monitoring and periodic review of systems for continued compliance
Requirements:
Education:
Bachelor's degree in computer science, Information Technology, Engineering, or a related technical discipline. Advanced degrees or certifications in validation, quality, or regulatory affairs are a plus.
Experience:
mmap Minimum of 3‑5 years of experience in computer systems validation within regulated industries (pharmaceutical, biotech, medical devices, etc.)جعExperience with FDA 21 CFR Part 11, GAMP 5, and other regulatory guidelines
Skills:
Strong knowledge of validation principles, risk management, and GxP environmentsProficient in creating and maintaining validation documentationStrong analytical and problem‑solving skillsAbility to manage multiple validation projects concurrentlyExcellent communication and interpersonal skillsKnowledge of software development life cycle (SDLC) is a plus
Why Join Catalyx?
At Catalyx we understand that our people are our greatest asset. For this reason and many others, weRIEND care of them. The team benefits from a total rewards package, including great personal benefits and professional growth opportunities.
Equal Opportunity Statement
Catalyx is an Equal Opportunity Employer. We are committed to creating a diverse and inclusive workplace where all individuals are valued, respected, and supported. We do not discriminate on the basis of race, colour, religion, sex (including pregnancy, gender identity, and sexual orientation), national origin, age, disability, veteran status, genetic information, or any other characteristic protected by applicable law. We encourage applications from all qualified candidates, regardless of background, and strive to create a welcoming environment for everyone.
At Catalyx, we are committed to attracting the best global talent. We proudly support our international employees by offering assistance with Critical Skills Visa applications for eligible candidates.
To be considered for this role you will be redirected to and must complete the application process on our careers page. To start the process, click the Apply button below to Login/Register.
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