The Role
- Labs Systems Validation Engineer
- Dublin
- Onsite role. South Dublin location and fully onsite
- Permanent or Contractor Opportunity
Role Brief
The successful candidate will be responsible for OT systems and will have overall responsibility for all IT/OT aspects of Lab and production IT systems validation.
Some Key Responsibilities:
- Provide front line support for operational issues, asset replacement, system upgrades on all Laboratory and Production OT systems
- Manage, develop, follow, and enforce the processes and procedures for Laboratory and Production OT systems to ensure a consistent and reliable OT service
- Execute periodic duties, such as Periodic Reviews, Data Integrity Assessments, System Impact Assessments, Cyber Security Risk Assessments, Remediation, Backups, etc, to ensure compliance, business continuity, and the qualified status of the Laboratory and Production OT systems
- Build and/or maintain a system of quality GxP documentation in accordance with the local site and global quality procedures
- Provide OT technical guidance and support as required to ensure successful delivery of projects into the Laboratories and Production Systems
- MES Application IT Administration
- Manage vendor SLA’s for various software and hardware maintenance.
- Manage the development of the local OT equipment inventory and configurations.
- Develop a deep understanding and provide guidance on the IT/OT change management procedures.
Skills Brief
Essential:
- At least 3 years’ hands-on experience providing Lab IT systems support in the biotechnology or pharmaceutical industries.
- Knowledge of regulatory requirements such as EU cGMPs, FDA, Annex 11/21CFR Part 11, GAMP 5 and data integrity guidelines.
- Experience in supporting infrastructures and applications; or equivalent position.
- Experience of server and/or workstation platforms, both physical and virtual.
Preferred:
-
- At least 2 years’ hands-on experience with Control System Validation (CSV) activities within a regulated Industry.
- At least 2 years’ hands-on experience with MES application IT Administration support.
Person Brief
Candidates must have a minimum of a bachelor’s degree in an Engineering/IT discipline with at least 3 years’ experience working in an IT hardware and software installations support role.
Strong labs systems and general validation experience in a GMP environment is essential for this role.
The ideal candidate will have excellent communication skills and strong problem skills.
The role is an onsite designated role in South Dublin and you must live in or close to this area and be able to comfortably commute to the site daily.
Opportunity Brief
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.
You will work in a stable industry with real long term development and advancement prospects and you will have the opportunity to build tailored software solutions for some of the biggest organisations in the world.
SL Controls offers a supportive environment committed to employee development and wellness, along with a competitive and rounded compensation package, which rewards high performers.
Company Brief
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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