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  • Validation Engineer Ireland
  • Sl Controls in Ireland, , Ireland
  • jobs
  • 5 days ago

jobs description

Job Title
Validation Engineer – Quality

The Role

Validation Engineer

Sligo

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:

Coordination / direction and active participation in the validation and quality assurance of site equipment, utilities, processes and software in compliance with company policies, FDA, European cGMP and GAMP standards

Generation/maintenance/execution of the Site Validation Master Plan

Generation/maintenance/execution of Project Validation Plans and schedules.

Generation of validation protocols and final reports to cGMP standards.

Generation of validation investigations and implementation of corrective... actions.

Creation/Review/Approval of various quality documents and test data.

Management of validation, exception event, and change control processes.

Maintenance and tracking of validation equipment, if applicable.

Completing all required training before executing a task.

Documenting all activities in line with cGMP requirements.

Updating of validation procedures, job instructions and batch documentation to reflect current best practices.

Performing cross training within the team and training of new team members.

Participation in continuous improvement programs to implement improvements in manufacturing, quality, safety and training systems.

Coordinating activities to maximize the effectiveness of all of the team members.

Maintaining the overall cGMP compliance of the production areas.

Communicating with peers and management regarding activities in the area, including elevation of events or concerns.

Skills Brief

Qualification and/or Degree in Engineering or Scientific discipline

3+ years Validation/Quality experience in medical device plastics processing, moulding or assembly operations.

3+ years of knowledge of cGMP and regulatory requirements relating to the medical device industry.

Strong communication (written and oral), presentation and troubleshooting skills required

Effective interpersonal and organizational skills.

Ability to work well both independently and in a team environment.

Capable of prioritizing work and multitasking.

Person Brief

This position is crucial in identifying systems and processes requiring validation/quality assurance support and ensuring that those activities are documented, actioned, and resolved in a timely fashion. Good communication and motivation ability is also required.

The successful candidate will have skills within the following areas:

Leadership/Influence

Decision making/Impact

Supervisory experience

Ownership/Accountability

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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