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Full-time
bachelor degree
Posted 3h ago
~40 hrs/week
Responsibilities
The CSV Engineer ensures all computerized systems in a pharmaceutical environment are validated and compliant with industry regulations. This includes authoring validation protocols, managing change controls, and collaborating with cross-functional teams to support system implementation.
Requirements
Candidates must hold a degree in Engineering, Computer Science, or Life Sciences with demonstrated CSV experience in regulated industries. Proficiency in GxP, GAMP 5, and the development of IQ/OQ/PQ protocols is required.
Full job description
Job Title: Computer System Validation (CSV) Engineer
Location: On-site (Limerick)
Role Overview:
The CSV Engineer will be responsible for ensuring that all computerised systems within the pharmaceutical environment are validated in compliance with industry regulations and company requirements. This specialist role supports the implementation, qualification, and ongoing compliance of automated systems used throughout manufacturing, laboratory, and business processes.
Key Responsibilities:
Plan, author, execute, and maintain validation protocols and documentation for new and existing computer systems (including manufacturing, laboratory, and business systems).
Ensure all CSV activities comply with relevant regulatory standards (e.g., FDA 21 CFR Part 11, EU Annex 11, GAMP 5, GMP).
Collaborate with IT, QA, Engineering, and Operations teams to identify, scope, and manage CSV projects.
Review and approve lifecycle documents, including User Requirements Specifications (URS), Functional/Design Specifications, Risk Assessments, IQ/OQ/PQ protocols, and validation summary reports.
Participate in system implementation projects, supporting system development, testing, and deployment activities.
Manage changes to validated computer systems through formal change control processes.
Conduct periodic reviews and re-validation activities as required.
Support investigations, deviations, CAPAs, and audits relating to computer systems.
Provide training and guidance to cross-functional teams on CSV requirements and practices.
Keep up to date with regulatory trends and technology changes impacting CSV.
Candidate Requirements:
Degree in Engineering, Computer Science, Life Sciences, or related discipline.
Demonstrated experience in CSV within the pharmaceutical or other regulated industries.
Strong knowledge of regulations, quality standards, and best practices for computer systems validation (GxP, GAMP 5, FDA 21 CFR Part 11, Annex 11).
Experience developing and executing validation protocols (IQ/OQ/PQ) for manufacturing, lab, or business systems.
Understanding of SDLC concepts, test methodologies, and change management in a regulated environment.
Excellent analytical, documentation, and problem-solving skills.
Effective communication and interpersonal skills; able to work independently and collaboratively.
Attention to detail and commitment to compliance and quality.
Preferred Skills:
Experience with automated manufacturing and laboratory systems, MES or LIMS.
Previous participation in regulatory audits or inspections.
Familiarity with project management tools and methodologies.
Now part of the Efor Group | Committed To Excellence
Industry
Pharmaceutical Manufacturing
Company size
201-500 employees
Headquarters
Toronto, Ontario
LinkedIn followers
41,286
PharmEng Technology, now part of Efor Group, leader in Compliance Engineering, is a leading provider of technical services and solutions to the pharmaceutical, biotechnology, and healthcare industries. With over 25 years of experience, we specialize in Commissioning, Qualification, and Validation (CQV) services for facilities, utilities, equipment, and processes.
As part of Efor’s global network of 3,000 experts across 12 countries, we are better equipped than ever to deliver innovative and comprehensive solutions tailored to the unique needs of clients worldwide. This integration strengthens our ability to combine global expertise with local proximity, positioning PharmEng as a strategic partner for the industry’s most prominent players.
Our team of highly skilled professionals brings a wealth of industry expertise and knowledge to every project, ensuring that our clients receive the highest quality services and solutions. We pride ourselves on our ability to provide flexible, innovative, and cost-effective solutions that meet our clients' unique challenges.
At PharmEng Technology by Efor, we are committed to delivering excellence in everything we do. We work closely with our clients to understand their goals and objectives, developing customized solutions that deliver measurable results. Our focus on quality, safety, and compliance ensures that our clients can trust us to meet their most critical needs.
Specialties: PharmEng Technology specializes in the planning, design, construction, and validation of Health Care, Laboratory, API Pharmaceutical, and Biotechnology facilities and equipment, including computer systems. We provide professional services that meet both regulatory and business demands, following current Good Manufacturing Practices (cGMP), Good Engineering Practices (GEP), and Good Laboratory Practices (GLP).
Offices: 23 Lesmill Road, Suite 410, Toronto, Ontario M3B 3P6, CA · 2475 Northwinds Parkway, Suite 200, Alpharetta, Georgia 30009, US · 2500 Regency Pkwy, Cary, North Carolina 27518, US · 866 Yuhangtang Road, Hangzhou, CN · 116c 2F Quang Trung Street, Haoni City, VN
How many Healthcare jobs are open in Limerick, Ireland right now?
There are currently 40 open healthcare positions in Limerick, Ireland listed on Clera. New openings are added daily as companies post roles.
Which companies are hiring for Healthcare roles in Limerick, Ireland?
Companies currently hiring include Johnson & Johnson Innovative Medicine, Edwards Lifesciences, Regeneron, PM Group, Bon Secours, among others. Browse the listings above to see every active employer.
Are there remote or hybrid Healthcare jobs in Limerick, Ireland?
Yes — 7 of the 40 open healthcare positions offer remote or hybrid work (0 remote, 7 hybrid).
How do I apply for Healthcare jobs in Limerick, Ireland?
Each listing links directly to the employer's application page. Apply early — fresh listings get the most recruiter attention in the first two weeks.