Equipment System Integration Solutions
SL Controls is a leading provider of innovative solutions to manufacturers, particularly those in the life sciences and technology sectors. Our continued growth and expansion present exciting opportunities for engineers.
We have multiple roles available in various locations across Ireland and in our USA office. Our engineers design and implement cutting-edge Smart Factory and Industry 4.0 solutions, making this work rewarding and challenging. Additionally, we offer excellent prospects for career advancement.
The Role:
* Computer Systems Validation Engineer
* Kilkenny
* This is an onsite role with some remote work possible; however, daily presence at the site is expected.
* Permanent or Contract opportunity available
Role Brief:
You will work closely with a major SL Controls client in the Pharma sector to validate and manage computerized systems within a high-tech regulated manufacturing environment.
Core Responsibilities:
* Validate and operate computerized systems.
* Create and review validation documentation according to regulatory requirements and divisional policies.
* Develop Software Compliance assessments, including 21 CFR Part 11 and Data Integrity.
* Maintain quality and compliance status of associated procedures and work instructions.
* Present and communicate status reports, identify trends, potential issues, and improvement initiatives as applicable.
Skills Brief:
* Strong experience in CSV for manufacturing systems and large-scale applications.
* Fully understand 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.
Person Brief:
* A Level 8 degree in Computer Science, IT, Pharmaceutical Manufacturing, or a highly related discipline is required.
* At least 2 years' experience in a computer systems validation role in Pharma, Life Sciences, or Medical Devices is essential; only candidates with this experience can be considered.
* The ideal candidate will have excellent collaboration and communication skills, strong attention to detail, and the ability to effectively communicate and present to various levels of leadership.
* Ability to think logically and proactively.
* Must be flexible and able to manage multiple priorities simultaneously.
* Must have excellent organizational skills.
* Daily onsite presence is mandatory; some remote working may be available but requires full-time onsite commitment.
Opportunity Brief:
This is an exceptional chance to collaborate with global leaders in their field, contributing to the development and enhancement of industry-leading technology solutions. NNIT Ireland offers a supportive environment focused on employee development and wellness, along with a competitive compensation package that rewards high performers.
Company Brief:
NNIT Ireland specializes in Equipment System Integration and System Support. We assist clients, including top multinational companies in the medical device and pharmaceutical sectors, in achieving their Six Sigma and OEE targets.
We have grown from a Sligo-based enterprise into an international business with offices in Galway, Limerick, Leinster, and Florida, USA over the past 20 years.
We pride ourselves on our expertise in industrial IT integration and regulatory compliance supporting global end users, OEMs, and Technology providers.