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Validation Engineer - Job Opportunity at Hartley People

Waterford, Ireland
Full-time
Mid-level
Posted: June 12, 2025
On-site
EUR 55,000 - 70,000 annually based on the mid-level experience requirements, Ireland's competitive pharmaceutical sector wages, and the specialized regulatory knowledge demanded for medical device and pharmaceutical validation roles in the Waterford region

Benefits

Comprehensive health coverage through private medical insurance providing superior healthcare access and reduced out-of-pocket expenses
Secure retirement planning with company pension scheme offering long-term financial stability
Health and wellness support through paid sick leave ensuring job security during illness
Environmental sustainability incentive through bike-to-work scheme promoting healthy commuting with tax benefits
Convenient on-site parking eliminating daily commuting stress and additional parking costs
Performance-based yearly bonus structure providing additional income potential tied to company and individual success

Key Responsibilities

Drive regulatory compliance excellence by developing and executing comprehensive validation strategies that ensure adherence to HPRA, FDA, and international regulatory standards, directly impacting product market access and company reputation
Lead quality documentation governance by preparing and maintaining critical validation documentation that serves as the foundation for regulatory submissions and audit readiness
Foster cross-functional collaboration by integrating validation requirements into broader operational initiatives, ensuring seamless project execution and organizational alignment
Manage strategic vendor relationships by coordinating external validation activities and ensuring alignment with company standards, optimizing resource utilization and project outcomes
Shape organizational quality strategy by creating master validation plans and conducting risk assessments within the Quality Management System, establishing frameworks for sustained compliance
Champion regulatory excellence by supporting GMP requirements and safety initiatives across all validation activities, maintaining the highest industry standards
Drive continuous improvement culture by contributing to quality audits and implementing LEAN and Six Sigma methodologies, enhancing operational efficiency and reducing costs

Requirements

Education

Degree in Engineering or Science discipline

Experience

3–5 years of experience in a validation or quality engineering role within a regulated industry

Required Skills

Solid knowledge of process and method validation Process characterization experience Familiarity with ISO13485, GAMP5, FDA regulations, ISO14644, and EudraLex Experience using LEAN and Six Sigma tools
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Sauge AI Market Intelligence

Industry Trends

The medical device and pharmaceutical validation sector is experiencing unprecedented growth driven by increasing regulatory scrutiny following high-profile product recalls and safety incidents, creating demand for validation engineers who can navigate complex multi-jurisdictional compliance requirements across HPRA, FDA, and EMA frameworks. Digital transformation in pharmaceutical manufacturing is driving adoption of Industry 4.0 technologies including process analytical technology (PAT), continuous manufacturing, and data integrity systems, requiring validation engineers to develop expertise in GAMP5 computerized system validation and advanced statistical process control methods. Post-Brexit regulatory landscape changes have created new opportunities in Ireland as pharmaceutical companies establish or expand EU manufacturing operations to maintain market access, particularly benefiting validation professionals with experience in both FDA and European regulatory frameworks. Quality by Design (QbD) principles are becoming mandatory rather than optional in pharmaceutical development, requiring validation engineers to integrate risk-based approaches with traditional validation methodologies and demonstrate enhanced understanding of process characterization and lifecycle management.

Role Significance

Typically manages 2-4 junior validation technicians while collaborating with 8-12 cross-functional team members including quality assurance, manufacturing, regulatory affairs, and external vendor teams in a matrix organizational structure
Mid-level professional role with significant autonomy in validation strategy development and cross-functional leadership responsibilities, positioned as a technical expert who influences quality decisions and regulatory compliance across multiple product lines and manufacturing processes

Key Projects

Leading comprehensive validation campaigns for new product launches requiring coordination of Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols across multiple manufacturing systems and processes Managing computer system validation projects for manufacturing execution systems (MES), laboratory information management systems (LIMS), and process control systems following GAMP5 methodology and 21 CFR Part 11 compliance requirements Conducting process validation studies for critical manufacturing processes including statistical analysis of process capability, establishment of proven acceptable ranges, and development of ongoing monitoring strategies for continued process verification

Success Factors

Mastery of risk-based validation approaches combining traditional validation methodologies with modern Quality by Design principles, enabling efficient resource allocation while maintaining rigorous compliance standards in an increasingly complex regulatory environment. Strong project management capabilities with ability to coordinate multiple concurrent validation activities across different product lines, manufacturing sites, and regulatory jurisdictions while maintaining strict timelines and budget constraints. Exceptional technical writing and communication skills for creating validation documentation that satisfies multiple regulatory audiences including HPRA, FDA, and notified bodies while serving as practical guidance for manufacturing and quality operations teams. Deep understanding of pharmaceutical manufacturing processes and analytical methods enabling effective collaboration with process development, manufacturing, and quality control teams to identify critical quality attributes and establish appropriate validation strategies.

Market Demand

High demand driven by Ireland's position as a major pharmaceutical manufacturing hub, stringent regulatory requirements following recent industry incidents, and the critical nature of validation roles in ensuring product safety and market access

Important Skills

Critical Skills

Process and method validation expertise forms the foundation of pharmaceutical manufacturing compliance, directly impacting product quality, patient safety, and regulatory approval timelines. This knowledge enables validation engineers to design scientifically sound validation studies that demonstrate process capability and establish ongoing monitoring strategies essential for maintaining manufacturing licenses. Regulatory framework knowledge spanning ISO13485, GAMP5, FDA regulations, ISO14644, and EudraLex provides the compliance foundation necessary for operating in global pharmaceutical markets. This multi-jurisdictional expertise is increasingly valuable as companies expand internationally and face harmonized but complex regulatory requirements across different health authorities. LEAN and Six Sigma methodologies represent critical skills for modern pharmaceutical manufacturing, enabling validation engineers to optimize validation approaches, reduce waste in validation activities, and contribute to operational excellence initiatives that directly impact manufacturing costs and efficiency while maintaining compliance standards.

Beneficial Skills

Process characterization experience provides advanced understanding of manufacturing science principles, enabling more effective validation strategy development and supporting Quality by Design approaches increasingly expected by regulatory authorities for modern pharmaceutical development programs. Vendor management and coordination skills become increasingly valuable as pharmaceutical companies outsource specialized validation activities to maintain operational flexibility and access cutting-edge expertise, requiring validation engineers who can effectively manage external relationships while ensuring compliance standards. Cross-functional collaboration abilities enable validation engineers to effectively integrate validation requirements into broader operational initiatives, supporting career advancement into management roles and enhancing overall organizational effectiveness in complex matrix organizational structures typical of pharmaceutical companies.

Unique Aspects

Opportunity to work across both medical device and pharmaceutical validation disciplines, providing broader regulatory experience than single-sector roles and enhanced career flexibility in the life sciences industry.
Direct involvement in master validation planning and Quality Management System development, offering strategic-level experience typically reserved for more senior positions and accelerating professional development.
Integration of modern continuous improvement methodologies including LEAN and Six Sigma with traditional validation practices, providing experience in operational excellence approaches increasingly demanded by pharmaceutical manufacturers.
Collaboration with external vendors on validation activities, developing vendor management and outsourcing skills crucial for modern pharmaceutical operations where specialized validation services are increasingly outsourced to maintain flexibility and access specialized expertise.

Career Growth

Advancement to senior validation engineer typically occurs within 2-3 years with demonstrated technical excellence and project leadership, while progression to management roles generally requires 4-6 years with additional development in people management, budgeting, and strategic planning capabilities

Potential Next Roles

Senior Validation Engineer with expanded responsibility for validation strategy across multiple sites and product portfolios, including mentoring junior staff and leading complex multi-site validation projects Validation Manager overseeing entire validation department with budget responsibility, strategic planning accountability, and direct reports managing various validation disciplines including facilities, equipment, processes, and computer systems Quality Assurance Manager or Director role leveraging validation expertise to oversee broader quality operations including supplier quality, change control, deviation investigations, and regulatory interactions with health authorities

Company Overview

Hartley People

Hartley People operates as a specialized recruitment consultancy focusing on pharmaceutical, medical device, and life sciences sectors, representing a leading medical device and pharmaceutical manufacturing company in Waterford that demonstrates significant market presence through their emphasis on regulatory compliance and quality systems.

The client company represents a well-established player in the Irish pharmaceutical manufacturing sector, evidenced by their comprehensive regulatory compliance requirements spanning multiple international jurisdictions and their investment in advanced quality management systems including LEAN and Six Sigma methodologies.
Waterford location positions the company within Ireland's pharmaceutical corridor, benefiting from proximity to other major pharmaceutical manufacturers, specialized supply chains, and access to experienced regulatory and quality professionals, while maintaining strategic access to European markets through Ireland's EU membership.
Professional environment emphasizing regulatory excellence, continuous improvement, and cross-functional collaboration, with strong focus on employee development through exposure to international regulatory standards and modern quality methodologies, supported by comprehensive benefits package indicating commitment to employee retention and satisfaction.
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