Job Title:
Validation Engineer
Location:
Galway City, Ireland
Department:
Quality
Reporting To:
Group Validation Lead
Contract Type:
24-Month Fixed Term
Overview
An exciting opportunity has arisen for a talented and experienced
Validation Engineer
to join a world-leading medical device manufacturer in
Galway City
.
Representing our client, a global leader in cardiovascular technology, we are looking for a dynamic professional who can take ownership of
Test Method Validation (TMV)
activities and drive excellence in quality and compliance.
Role Summary
The successful Validation Engineer will play a critical role in
developing, documenting, and implementing robust Test Method Validation (TMV) operating procedures
.
This position requires a strong understanding of
ISO, PMDA, and FDA
regulatory frameworks.
Acting as the subject matter expert within cross-functional teams, the engineer will guide early-stage projects, execute validations across all inspection stages (incoming, in-process, and final product), and perform in-depth statistical analysis to ensure test methods are accurate, precise, and repeatable.
Key Responsibilities
Lead and manage
Test Method Validation
activities in line with regulatory and internal requirements
Develop and approve
Standard Operating Procedures (SOPs)
and
Master Validation Plans & Reports
Estimate validation timelines and resource requirements, and coordinate validation schedules
Author and review
validation protocols
, reports, and supporting documentation
Ensure validation activities meet
ISO *****, PMDA, and FDA (21 CFR Part 820)
standards
Drive
risk management activities
, including
FMEA
and related assessments
Perform statistical analyses (e.g. Gage R&R, ANOVA) to evaluate test method performance
Provide
training and mentorship
to cross-functional teams on TMV best practices
Collaborate with external testing partners, reviewing methodologies, protocols and reports
Escalate risks or issues promptly and communicate progress to the Site Validation Lead
Candidate Profile
5–8 years
of hands-on experience in medical device manufacturing or validation roles
Minimum
Level 8 qualification
in Science, Engineering, or related discipline
Strong technical knowledge of
catheter-based medical devices will provide a distinct advantage
In-depth understanding of regulatory and validation requirements in the medical device sector
Proven track record of
delivering validation projects
on time and to high quality standards
Excellent skills in
data analysis, statistical techniques, and problem solving
Comfortable working in a
fast-paced, regulated environment
with cross-functional teams
Strong interpersonal and communication skills across all business levels
For further information on this role please contact Lisa Lawlor on or email
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