Computer Systems Validation Engineer (CSV Engineer) – Dublin
- Computer Systems Validation Engineer
- Onsite role
- Permanent or Contractor opportunity
The successful candidate will be responsible for ensuring conformance to quality systems, liaising with various departments, giving guidance, reviewing documentation and ensuring that validation work is being carried out as per the company validation policies & procedures.
This role will have responsibility for executing validation strategies for key software systems and infrastructure i.e. MES, ERP and QMS. You will provide advise on planning, monitoring and the execution of program rollouts. You will also help optimize and streamline manufacturing related operations.
- Contributing to the preparation & review of the Validation Master Plan
- Generating validation protocols & reports in accordance with cGMP & customer requirements
- Execution of protocols for equipment, process, utilities, methods & computerized systems
- Managing the execution of the equipment/software/process validation as per the MVP & project plan
- Experience of GxP Computerised Systems & familiar with GAMP5 guidelines
- Experience with OSI PI systems is desirable – system knowledge is required
- SAP system experience is highly advantageous
- Provide technical direction & hands-on assistance for testing projects
Candidates must have a Bachelor’s degree in Computer Science, Electricial Engineering, Systems Engineering, Technology or a related discipline with over 3-5 years’ experience as a Validation Engineer (mainly computer systems validation) in the Pharmaceutical or related Healthcare industry. The ideal candidate will have excellent collaboration and communication skills, strong attention to detail and an excellent understanding of validation concepts and documentation.
The role is based in Dublin and will be onsite in nature (occasional remote work but 90%+ onsite) so you must be based in the Dublin or the Dublin commuter area, or you should be willing to relocate to the area.
This is an excellent opportunity to work with clients who are global leaders in their field, helping to develop and improve upon industry leading technology solutions. SL Controls offers a supportive environment committed to employee development and wellness, along with a competitive and rounded compensation package, which rewards high performers.
SL Controls are experts in the area of Equipment System Integration and System Support. We specialise in assisting our customers, including many of the world’s top multinational companies in the medical device and pharmaceutical sectors, achieve their Six Sigma and OEE targets.
Over the past 20 years we have grown our business from a Sligo based enterprise into an international business with additional offices in Galway, Limerick, Leinster and Florida USA.
We pride ourselves on our expertise in industrial IT integration and regulatory compliance in support of global end users, OEM’s and Technology providers.
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