Process & Product Validation Engineer
- Process & Product Validation Engineer
- Onsite / Remote Hybrid
- 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 the company validation policies & procedures are being adhered to.
The role will be focused on working on a new EUMDR project.
- Managing & coordinating the preparation, review & issuing of Validation protocols & reports
- Managing & coordinating validation documentation (risk assessments, traceability matrices, validation reports)
- Creating validation test plans and making amendments where appropriate
- DHF, Validation documents, Risk Management documents will be in scope so you need to be able to review large volumes of documents and review/complete gap analysis
- Strong EUMDR experience highly preferred
- Validation Experience
- Generation of Validation Protocols/Reports
- Fundamentals of Validation
- DQ – Design Qualification, IQ – Installation Qualification, OQ – Operational Qualification, PQ – Performance Qualification, PV – Process Validation, CV – Cleaning Validation.
- Experience with FUE – Facilities, Utilities and Equipment Qualifications.
- Strong equipment side Validation experience
- Executing of Protocols.
- cGDP, cGMP experience
- Problem Solving skills
- FMEA Risk Assessments experience
- Electronic Records, Electronic Signatures knowledge and experience
Candidates must have a relevant science or engineering tertiary qualification with a minimum of 5 years’ experience in the medical devices, pharmaceutical or life sciences industry with strong experience in Equipment, Product & Process Validation. The ideal candidate will have excellent collaboration and communication skills, with a demonstrated understanding of manufacturing processes and related process equipment. In addition to this, strong attention to detail and an excellent understanding of validation concepts and documentation is required.
The candidate should be based within a reasonable commute of the site location as a mix of onsite and remote work will form the make up of 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 19 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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