1 day ago Be among the first 25 applicants
Get AI-powered advice on this job and more exclusive features.
Longford/Roscommon Ireland
CPL Recruitment are once again assisting our valued client source a
JO-2507-554382
Validation Engineer
Medical Device
Longford/Roscommon Ireland
CPL Recruitment are once again assisting our valued client source a Validation Engineer to join their team. This is an exciting opportunity to join a manufacturing site that has undergone major investment and expansion since 2022. You will be working with a very friendly and experienced team that have a wealth of experience in the leadership team.
Prior Medical Device And/or Injection Moulding Experience Essential.
Get in touch for further information : Deirdre Murphy on 01 614 6178 / 087 180 4358 or deirdre.murphy@cpl.ie
Role
* 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.
Requirements
* 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
* Experience as a Validation Engineer within an Injection moulding or medical manufacturing environment essential.
Seniority level
* Seniority level
Entry level
Employment type
* Employment type
Full-time
Job function
* Job function
Quality Assurance
* Industries
IT Services and IT Consulting
Referrals increase your chances of interviewing at Cpl Technology - Tech Recruitment Experts by 2x
Get notified about new Validation Engineer jobs in Longford, County Longford, Ireland.
Longford, County Longford, Ireland $50,000.00-$70,000.00 2 days ago
Longford, County Longford, Ireland 11 hours ago
Longford, County Longford, Ireland 2 months ago
Longford, County Longford, Ireland 2 days ago
Roscommon, County Roscommon, Ireland 4 months ago
Senior Quality Validation Engineer - Medtronic Athlone
Athlone and Bigmeadow, County Westmeath, Ireland 6 days ago
Senior Quality Systems Engineer (m/f/x)*
Longford, County Longford, Ireland 9 hours ago
Senior Software Quality Systems Engineer
Longford, County Longford, Ireland 2 weeks ago
We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.
#J-18808-Ljbffr