Computer Systems Validation Engineer Role
* Onsite role in Kilkenny with possible remote work
* Permanent or contractor opportunity
Job Overview:
As a Computer Systems Validation Engineer, you will work with a major client in the Pharma sector to validate and manage computerized systems within a high-tech regulated manufacturing environment.
Main Responsibilities:
* Validation and operational management of computerized systems
* Creation and review of validation documentation according to regulatory requirements and divisional policies
* Responsible for creating Software Compliance assessments (21 CFR Part 11 and Data Integrity)
* Maintenance of quality and compliance status of associated Procedures and work instructions
* Presentation and communication of status, report metrics, identify trends, potential issues, and improvement initiatives
Key Skills:
* Strong experience in CSV for manufacturing systems and large-scale applications
* Full understanding of cGMP requirements, including 21 CFR 11 and Annex 11
* Excellent understanding of GAMP principles and validation concepts
* Demonstrated analytical and problem-solving capabilities
* Strong technical writing skills
Ideal Candidate:
* Bachelor's degree in Computer Science/IT/Pharmaceutical Manufacturing or related field
* Minimum 2 years' experience in computer systems validation role in Pharma, Life Sciences, or Medical Devices
* Excellent collaboration and communication skills, strong attention to detail, and ability to present effectively
* Logical thinking and proactive approach
* Flexibility to manage multiple priorities simultaneously
* Excellent organizational skills
* Able to commute daily to the site
Opportunity:
This is an excellent opportunity to work with global leaders in their field, developing and improving industry-leading technology solutions. SL Controls offers a supportive environment committed to employee development and wellness, along with a competitive compensation package.
About SL Controls:
SL Controls specialize in Equipment System Integration and System Support. We assist our customers, including top multinational companies, achieve their Six Sigma and OEE targets. With over 20 years of experience, we have grown into an international business with offices in Ireland and the USA.