Systems Validation Engineer – Remote
- Systems Validation Engineer
- Remote role
- Contractor opportunity
The successful candidate will act as a validation SME for the operations area and support validation activities across the department primarily focusing on process, software and test method validation for an SL Controls client.
- Managing & coordinating the preparation, review & approval of Validation Master Plans
- Generate, execute and review validation protocols and associated reports for related process, software and test method validation activities.
- Managing & coordinating of all validation strategies & deliverables
- Managing & coordinating the preparation, review & issuing of validation protocols & reports
- Managing & coordinating validation documentation (risk assessments, traceability matrices)
- Managing & coordinating the review & approval of specifications associated with Equipment & Processes.
- Managing & coordinating routine Internal Quality Audits of the facility to ensure compliance & be proactive in resolving issues that may arise.
- Provide technical direction & hands-on assistance for testing projects
- CFR 21 Part 11 experience and experience of Lab Systems Validation are essential.
Candidates must have a Bachelor’s degree in Computer Science, Electrical Engineering, Systems Engineering, Technology or a related discipline with over 3 years’ experience as a Validation Engineer in the Pharmaceutical or related Healthcare industry. You should ideally have at least 1 years of experience in the manufacture/testing of diagnostic products.
The ideal candidate will have excellent collaboration and communication skills, strong attention to detail and an excellent understanding of validation concepts and documentation. He/she should also have proven ability to solve complex technical & equipment qualification challenges using a rational scientific approach.
This role is based in Longford but can be offered remotely or predominantly remotely but you must be able to travel to site if this is needed occasionally. You must be based in Ireland to be considered for this role.
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 and benefits 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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