Job Title

Validation Engineer

The Role

  • Validation Engineer
  • Longford
  • Onsite Role
  • Contractor or Permanent opportunity

Role Brief

The successful candidate will be responsible for supporting all validation activities associated with the successful qualification of new tools / product introductions.

You will report to the Quality Manager and support the organization to achieve the new product introduction objectives.

Main responsibilities:

  • Write and execute process validation protocols and reports for new product introductions and revalidations due to process /material improvements utilizing scientific / technical knowledge.
  • Developing and implementing solutions to sustain and improve the QMS.
  • Maintain and support compliance to ISO 13485 and ISO 14001 systems standards.
  • Participate in the site change control, ensuring that all changes to validated processes are effectively identified and implemented.
  • Generation of risk assessments, covering cleaning, validation, and process.
  • Review and execution of Factory Acceptance Testing and Site Acceptance Testing protocols.
  • Directly supports GMP and regulatory audits.
  • Prepare and deliver training modules as required.
  • Perform data analysis and make informed decisions / recommendations around conclusions reached from data analysis
  • Support continuous improvement through Lean Six Sigma methodologies.
  • Execution / development of change controls.
  • Perform root cause analysis of system failures, substandard performance, using standard tools and methods, to resolve machine and system issues e.g., FMEA, Fishbone diagrams, 5 why’s etc.;
  • Implement subsequent corrective action through the change management system.
  • Participate / lead cross functional teams including liaising with vendors on projects

Skills Brief

  • Third level qualification in Engineering, Polymer Science, or equivalent Manufacturing experience.
  • Experience in statistical analysis (Minitab) / SPC / validations.
  • Excellent interpersonal, communication, influencing, and facilitation skills
  • A minimum of 3 years’ experience as a Validation Engineer within an Injection moulding or medical manufacturing environment

Person Brief

Candidates must have over 3 years’ experience in Validation Engineering & validation activities for equipment found in Pharmaceutical or other GMP regulated environments.

The ideal candidate will have excellent collaboration and communication skills, strong attention to detail and an excellent understanding of validation concepts and documentation. You should also have proven ability to solve complex technical & equipment qualification challenges using a rational scientific approach.

The candidate should be based in Longford or within a reasonable commute or be willing to relocate to the area in the immediate future as the role will be onsite in nature.

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 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.

Find out more about working at SL Controls, our Sustainable Development Goals, and our Diversity, Equity, and Inclusion policy.

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