Validation Engineer - Contract
Location: Longford, Ireland
The Validation Engineer is responsible for supporting all validation activities associated with the successful qualification of new tools and the introduction of new products.
This role ensures that validation processes meet regulatory requirements, internal quality standards, and project timelines.
Reporting to the Validation Engineering Manager, the Validation Engineer will play a critical role in driving new product introduction (NPI) objectives while supporting continuous improvement and maintaining compliance across quality systems.
Key Responsibilities
Process Validation:
Write, execute, and maintain process validation protocols and reports for new product introductions and revalidations resulting from process or material improvements, applying strong scientific and technical knowledge.
Conduct data analysis and provide informed, evidence-based recommendations and conclusions.
Quality & Compliance:
Support the development, implementation, and ongoing improvement of the Quality Management System (QMS).
Maintain and ensure compliance with ISO ***** and ISO ***** system standards.
Participate in and support GMP and regulatory audits.
Generate comprehensive risk assessments covering cleaning, process validation, and equipment.
Change Control:
Participate in site change control processes, ensuring all changes to validated processes are appropriately identified, assessed, and implemented.
Execute and develop change controls in accordance with internal procedures.
Implement corrective and preventive actions (CAPA) resulting from investigations and process changes.
Equipment Qualification & Testing:
Review and execute Factory Acceptance Testing (FAT) and Site Acceptance Testing (SAT) protocols.
Troubleshoot equipment or system issues and perform root cause analysis using standard problem-solving methodologies (e.g., FMEA, Fishbone, 5 Whys).
Continuous Improvement:
Support and apply Lean Six Sigma methodologies to drive process improvements and enhance operational efficiency.
Cross-Functional Collaboration:
Participate in and/or lead cross-functional teams to support project delivery.
Liaise with equipment suppliers and external vendors as required.
Prepare and deliver training modules related to validation activities and procedures.
Qualifications & Key Attributes
Third-level qualification in Engineering, Polymer Science, or a related field; equivalent relevant manufacturing experience will also be considered.
Minimum of
2 years' experience as a Validation Engineer
, preferably within an injection moulding or medical device manufacturing environment.
Strong interpersonal, communication, influencing, and facilitation skills.
Experience with statistical analysis tools (e.g., Minitab), Statistical Process Control (SPC), and validation methodologies.
Fluent in English with excellent written and verbal communication skills.
Demonstrated ability to solve problems using structured tools and methods.
Ability to work effectively in a fast-paced, regulated manufacturing environment.
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