QA Validation Engineer

1 week ago

Galway, Ireland SL Controls Ltd Full time

The Role QA Validation Engineer
Sligo
Onsite Role
Permanent or Contractor Opportunity
Role Brief In this role you will be responsible for coordinating the development and maintenance of the site validation program for an NNIT client. Your role will be to ensure external regulatory, quality, and compliance requirements are met. You will be directly involved in the coordination, implementation and development of the site Validation Program and general Quality Assurance activities.
Core Tasks Coordination / direction and active participation in the validation and quality assurance of site equipment, utilities, processes and software in compliance with client 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.
Documenting all activities in line with cGMP requirements.
Maintaining the overall cGMP compliance of the production areas.
Skills Brief Over 2 years plus validation experience in medical device plastics processing, molding or assembly operations.
Proven knowledge of cGMP and regulatory requirements relating to the medical device industry.
Strong documentation and review skills and experience.
Experience of the development and maintenance of a site validation master plan within the Medical Devices or Life Sciences manufacturing sector.
Person Brief Candidates must have a Bachelor’s degree in Computer Science, Electrical Engineering, Systems Engineering, Technology or a related discipline with over 3 years’ experience of Validation Engineering. You should have at least 2 years of experience of Validation activities for equipment found in Medical Devices, 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. He/she should also have proven ability to solve complex technical & equipment qualification challenges using a rational scientific approach.
The candidate should be based in Sligo or within a reasonable commute or be willing to relocate to the area as the role will be onsite.
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. NNIT offers a supportive environment committed to employee development and wellness, along with a competitive and rounded compensation package, which rewards high performers.
Company Brief NNIT is a publicly listed company that specializes in IT solutions to life sciences internationally, and to the public and enterprise sectors in Denmark. We focus on high complexity industries and thrive in environments where regulatory demands and complexity are high. We advise on and build sustainable digital solutions that work for the patients, citizens, employees, end users or customers. NNIT employs more than 1,800 people in Europe, Asia, and USA.

#J-18808-Ljbffr

  • Qa Validation Engineer

    4 weeks ago

    Galway, Galway, Ireland Team Horizon Full time

    Team Horizon is seeking a QA Validation Engineer on an initial 12-month contract for a Medical Device manufacturer in the Connaught region.Why you should apply: You have experience in Quality / Validation engineering, enjoy a new challenge and have experience working on a range of projects.You enjoy working with a diverse team on interseting projects, and...

  • Senior Manufacturing Qa

    5 days ago

    Galway, Ireland Reperio Human Capital Full time

    Social network you want to login/join with:Senior Manufacturing QA - Medical Devices, Galwaycol-narrow-leftClient:Location:Galway, IrelandJob Category:Other-EU work permit required:Yescol-narrow-rightJob Reference:d435d760bb7fJob Views:10Posted:Expiry Date:col-wideJob Description:Senior Manufacturing QA - Medical DevicesDesired skills:QA, QMS, RA, Medical...

  • Validation Engineer

    3 days ago

    Galway, Ireland Cregg Full time

    CREGG are now recruiting for a Validation Engineer.This is a fantastic opportunity to join a world leading Medical Device company in Co.Galway, working as a Validation Engineer working on the latest projects and state of the art equipment.This role offers great working flexibility with great career progression opportunities.The role:Responsibilities include...

  • Senior Manufacturing QA

    4 days ago

    Galway, Ireland Reperio Human Capital Full time

    Senior Manufacturing QA - Medical Devices 171718 Desired skills: QA, QMS, RA, Medical Devices, Galway HybridAn innovative and fast-scaling medical device company is seeking a Senior Manufacturing QA Engineer to support commercial manufacturing of a cutting-edge connected health solution for chronic wound care.This role is ideal for a quality professional...

  • Senior / Lead QA Automation Engineer

    4 days ago

    Galway, Ireland Reperio Human Capital Full time

    Senior / Lead QA Automation Engineer 170425 Desired skills: QA, Test, Automation, AI HybridA leading technology-driven organization working on cutting-edge AI software solutions is seeking a QA Automation Engineer. This is a unique opportunity to contribute to highly innovative products by ensuring the highest standards of software quality through advanced...

  • Emc Validation Engineer

    2 weeks ago

    Galway, Ireland Team Horizon Full time

    Social network you want to login/join with:Team Horizon is seeking an EMC Validation Engineer for a leading manufacturing company based in North Galway.The role is responsible for all EMC Validation activities from RFQ phase to final customer acceptance of a defined project.It runs the activities for one project according to company rules and international...

  • Senior Qa Engineer

    2 weeks ago

    Galway, Ireland Soteria Reinsurance Ltd. Full time

    Senior QA Engineer page is loaded## Senior QA Engineerlocations: Galway, Irelandtime type: Full timeposted on: Posted Todayjob requisition id: 2117665## ## Job Description:**The Role**As a Senior Quality Engineer, you will be immersed in every aspect of product development.Your independent voice will ensure that quality is engineered into the product.You...

  • QA Lead

    9 hours ago

    Galway, Ireland Reperio Human Capital Full time

    QA Lead (Contract) 173701 Desired skills: Test automation, Test Lead , frameworks, Programming, Software Testing, Contract HybridReperio has partnered with a well-known organisation in Galway that’s looking for a QA Engineer on a 12-month contract, with the possibility of extension. This hybrid role (3 days on-site) offers a competitive daily...

  • Senior Design Assurance Engineer

    2 days ago

    Galway, Ireland Barrington James Full time

    Overview We are partnering with a growing medical device company to appoint a Senior Design Assurance Engineer in Galway. This role will give you the chance to take ownership of QA activities across the full product lifecycle, from design and development through to commercialisation. Responsibilities Lead risk assessments, design verification/validation,...

  • (High Salary) Senior QA Engineer

    2 weeks ago

    Galway, Ireland Soteria Reinsurance Ltd. Full time

    Senior QA Engineer page is loaded## Senior QA Engineerlocations: Galway, Irelandtime type: Full timeposted on: Posted Todayjob requisition id: 2117665## ## Job Description:**The Role**As a Senior Quality Engineer, you will be immersed in every aspect of product development. Your independent voice will ensure that quality is engineered into the...