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Validation Engineer - County Waterford (DT18521) - Job Opportunity at ICDS Recruitment Consultants

Waterford, Ireland
Full-time
Mid-level
Posted: June 27, 2025
On-site
EUR 45,000 - 60,000 per year based on the mid-level experience requirements, specialized regulatory knowledge, and Ireland's competitive life sciences market. The salary range reflects the high demand for validation expertise in County Waterford's growing pharmaceutical and medical device sector.

Key Responsibilities

Lead the creation and execution of comprehensive validation documentation strategies that ensure regulatory compliance and operational excellence across manufacturing systems
Drive cross-functional validation initiatives that directly impact product quality, market access, and regulatory approval timelines for medical device and pharmaceutical products
Establish and maintain validation frameworks for critical manufacturing equipment including molding, assembly, and testing systems that support scalable production capabilities
Partner with external vendors and internal stakeholders to develop master validation plans that align with business objectives and regulatory requirements
Execute risk-based validation approaches that optimize resource allocation while maintaining the highest standards of Good Manufacturing Practice compliance
Lead quality audits and validation assessments that protect market authorization and ensure continuous improvement in manufacturing processes
Implement LEAN Six Sigma methodologies to drive operational efficiency and quality improvements across validation processes

Requirements

Education

Degree in Engineering/Science discipline

Experience

At least 3 to 5 years' experience in a Validation or Quality Engineering role

Required Skills

Strong working knowledge of process validation and capability Experience in method validation and process characterization Strong working knowledge of validation and quality principles and practices with key emphasis on EudraLex, ISO13485, ISO14644, GAMP5 and FDA Pharma and medical devices regulations Ability to work in a cross-functional team environment, with excellent initiative, decision-making and drive for achieving results Excellent technical report writing, time management, computer & presentation skills Excellent interpersonal and communication skills Knowledge and use of LEAN 6 sigma tools for problem solutions
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Sauge AI Market Intelligence

Industry Trends

The pharmaceutical and medical device industries in Ireland are experiencing significant growth driven by increased global demand for healthcare products and Ireland's position as a European manufacturing hub. This growth is creating substantial demand for validation engineers who can ensure compliance with increasingly stringent regulatory requirements. Digital transformation in manufacturing is driving the need for validation professionals with expertise in computerized systems validation, particularly GAMP5 guidelines, as companies implement Industry 4.0 technologies and automated quality systems. Post-Brexit regulatory landscape changes are creating additional complexity in validation requirements, with companies needing professionals who understand both FDA and EMA/HPRA requirements to maintain market access across multiple jurisdictions.

Role Significance

Typically works within a quality assurance team of 5-10 professionals, collaborating closely with manufacturing, engineering, and regulatory affairs departments. May lead validation projects involving 3-5 team members and coordinate with external vendors and regulatory consultants.
This is a mid-level specialist role with significant autonomy and cross-functional influence. The position carries substantial responsibility for regulatory compliance and quality assurance, with direct impact on product approvals and market access. The role requires independent decision-making and the ability to lead validation initiatives across multiple departments.

Key Projects

Implementation of comprehensive validation programs for new manufacturing equipment and facility expansions Development and execution of process validation protocols for new product launches and manufacturing process changes Leading computerized systems validation projects for manufacturing execution systems and quality management software Conducting validation gap analyses and remediation programs to address regulatory findings and maintain compliance

Success Factors

Deep understanding of regulatory requirements across multiple jurisdictions (FDA, EMA, HPRA) and the ability to translate these into practical validation strategies that support business objectives while ensuring compliance Strong project management capabilities and cross-functional leadership skills to coordinate complex validation activities across multiple departments and external partners Technical expertise in risk-based validation approaches and statistical process control to optimize validation strategies and reduce time-to-market for new products Excellent documentation and communication skills to create clear, defensible validation protocols and reports that can withstand regulatory scrutiny

Market Demand

High demand driven by Ireland's position as a global pharmaceutical manufacturing hub, with over 50 of the world's top pharmaceutical companies having operations in Ireland, creating continuous need for validation expertise to support manufacturing expansion and regulatory compliance.

Important Skills

Critical Skills

Regulatory knowledge of EudraLex, ISO13485, ISO14644, GAMP5, and FDA requirements is absolutely essential as these standards govern product approval and market access. Without this expertise, the validation engineer cannot ensure compliance or support business objectives effectively. Process validation and characterization skills are fundamental to the role as they directly impact product quality, manufacturing efficiency, and regulatory compliance. These skills determine the engineer's ability to establish and maintain validated manufacturing processes. Technical writing and documentation skills are crucial because validation work requires creating detailed protocols and reports that must withstand regulatory scrutiny and serve as legal documentation for compliance purposes.

Beneficial Skills

LEAN Six Sigma expertise provides additional value by enabling process optimization and cost reduction while maintaining quality standards, making the validation engineer a strategic business partner rather than just a compliance function Cross-functional collaboration and project management abilities enhance career prospects by demonstrating leadership potential and the ability to drive complex initiatives across organizational boundaries Risk assessment and management capabilities align with modern regulatory trends toward risk-based approaches, positioning the professional for advanced roles in quality assurance and regulatory strategy

Unique Aspects

The role combines both pharmaceutical and medical device validation expertise, providing broader career opportunities and deeper regulatory knowledge across two high-growth sectors
Emphasis on LEAN Six Sigma methodologies demonstrates the company's commitment to operational excellence and provides valuable process improvement skills that are highly transferable
Direct involvement in regulatory audits and vendor management provides exposure to external stakeholders and regulatory bodies, building valuable industry relationships
The comprehensive scope covering equipment, systems, and facilities validation offers diverse technical experience and career development opportunities

Career Growth

Progression to senior roles typically occurs within 2-3 years with demonstrated expertise and leadership capabilities. Management positions generally achievable within 4-6 years with appropriate experience and business acumen development.

Potential Next Roles

Senior Validation Engineer with expanded responsibility for validation strategy and team leadership Validation Manager overseeing validation programs across multiple sites or product lines Quality Assurance Manager with broader responsibility for quality systems and regulatory compliance Regulatory Affairs Specialist focusing on product registration and regulatory strategy

Company Overview

ICDS Recruitment Consultants

ICDS Recruitment Consultants is a specialized recruitment firm focusing on technical and scientific roles within Ireland's life sciences sector. The company serves as an intermediary between candidates and leading pharmaceutical, medical device, and biotechnology companies throughout Ireland.

Established recruitment consultancy with strong connections to Ireland's thriving life sciences industry, representing both multinational corporations and growing indigenous companies in the pharmaceutical and medical device sectors.
This role represents an opportunity within County Waterford's growing life sciences cluster, which includes several major pharmaceutical and medical device manufacturing facilities that serve global markets from Ireland's strategic European location.
Given the regulatory nature of the role and industry requirements, expect a structured, process-oriented work environment with strong emphasis on documentation, compliance, and continuous improvement. The collaborative nature of validation work promotes cross-functional teamwork and professional development.
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