Job Title

Senior Validation and Quality Engineer – Longford


The Role

  • Senior Validation and Quality Engineer
  • Longford
  • Onsite role with limited remote working possible
  • Permanent or Contractor Role

Role Brief

The successful candidate will have a senior level of responsibility for a specific area or function and 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 has both a quality assurance and hands on validation remit and will take ownership of a given task or set of tasks and may involve mentoring and guiding the work of more junior engineers.

Skills Brief

  • Medical devices validation and quality engineering experience and knowledge of EUMDR regulations a distinct advantage
  • Managing & coordinating the preparation, review & approval of the Validation Master Plans
  • Managing & coordinating the preparation, review & issuing of Validation protocols & reports
  • Managing & coordinating validation documentation (risk assessments, traceability matrices, validation reports)
  • Review of DHF’s & Risk Management Files
  • GAP analysis
  • Managing & coordinating the review & approval of specifications associated with Equipment, Processes, Products & Computerised Systems
  • Experience of GxP Computerised Systems and GAMP 5 a plus but not essential
  • Proficiency with Quality by Design (QbD) concepts and design of experiments a plus

Person Brief

Candidates must have a relevant science or engineering tertiary qualification with a minimum of 5 years’ experience in the pharmaceutical or life sciences industry with experience in Equipment & 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 role will be based in Longford and predominantly onsite. Limited remote working may be possible but only as per project requirements. You should be living within a reasonable commute of the Longford area and be available to be onsite daily if required.

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. 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.

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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