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Validation Engineer - Job Opportunity at ICDS Recruitment Consultants

County Waterford, Ireland
Full-time
Mid-level
Posted: August 6, 2025
On-site
EUR 45,000 - 55,000 annually based on the 1-3 years experience requirement, Irish market conditions, and the specialized nature of validation engineering roles in the pharmaceutical/medical device sector in regional Ireland locations

Key Responsibilities

Drive strategic validation initiatives across multiple critical systems including moulding, assembly, testing equipment, computerised systems and facilities, ensuring operational excellence and regulatory compliance
Lead the development and execution of comprehensive validation documentation that directly impacts product quality and regulatory approval timelines
Orchestrate cross-functional collaboration to integrate validation requirements into core business operations, influencing project outcomes and delivery schedules
Manage external vendor relationships for validation activities, controlling quality standards and project timelines that affect overall business performance
Champion GMP compliance initiatives and quality programs that protect company reputation and market access
Execute risk assessment processes that safeguard business continuity and regulatory standing
Lead quality audits that maintain certification status and competitive positioning
Apply LEAN Six Sigma methodologies to drive operational efficiency and cost optimization

Requirements

Education

Degree in Engineering/Science discipline

Experience

At least 1 to 3 years' experience in a Validation or Quality engineering role

Required Skills

Knowledge of process validation and capability Method validation and process characterization EudraLex ISO13485 ISO14644 GAMP5 FDA Pharma and medical devices regulations Cross-functional team environment collaboration Excellent initiative Decision-making Drive for achieving results Technical report writing Time management Computer skills Presentation skills Interpersonal and communication skills LEAN 6 sigma tools
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Sauge AI Market Intelligence

Industry Trends

The pharmaceutical and medical device industries are experiencing unprecedented regulatory scrutiny, with validation engineers becoming critical gatekeepers for market access as agencies like the FDA and EMA implement more stringent requirements for process validation and quality systems. This trend is driving increased demand for professionals who can navigate complex regulatory landscapes while maintaining operational efficiency. Digital transformation in manufacturing is revolutionizing validation processes, with computerized systems validation (CSV) and data integrity requirements becoming increasingly sophisticated. Companies are investing heavily in digital validation platforms and automated documentation systems, creating opportunities for validation engineers with strong technical and regulatory expertise. The shift towards risk-based validation approaches, particularly ICH Q9 quality risk management principles, is changing how validation activities are prioritized and executed. Organizations are moving away from traditional protocol-heavy approaches toward more strategic, science-based validation methodologies that focus on patient safety and product quality.

Role Significance

Typically operates within quality teams of 5-8 professionals, collaborating across engineering, manufacturing, and regulatory affairs departments in matrix organizational structures
Mid-level individual contributor role with significant technical responsibility and cross-functional influence, positioned as a subject matter expert who shapes validation strategies and ensures compliance across multiple business areas

Key Projects

Facility validation projects for new manufacturing lines or equipment installations Computer system validation for manufacturing execution systems and laboratory information management systems Process validation studies for new product launches or manufacturing process changes Remediation projects addressing regulatory findings or audit observations

Success Factors

Developing deep expertise in regulatory requirements across multiple jurisdictions while maintaining practical implementation knowledge that balances compliance with operational efficiency Building strong cross-functional relationships that enable effective collaboration with engineering, manufacturing, IT, and regulatory teams to drive validation projects to successful completion Mastering technical writing skills to create clear, defensible validation documentation that satisfies both internal quality standards and external regulatory expectations Cultivating strategic thinking abilities to assess validation requirements within broader business contexts and recommend risk-based approaches that optimize resource allocation

Market Demand

High demand driven by Ireland's position as a major pharmaceutical and medical device manufacturing hub, with significant investment from multinational companies requiring validation expertise for facility expansions and new product launches

Important Skills

Critical Skills

Regulatory knowledge of EudraLex, FDA, and ISO standards represents the foundational expertise that ensures all validation activities meet current requirements and anticipate regulatory evolution. This knowledge directly impacts product approval timelines and market access success. Technical writing capabilities are essential for creating validation documentation that serves as legal evidence of compliance during regulatory inspections and audits. Poor documentation can result in significant business disruptions and regulatory findings. Cross-functional collaboration skills enable effective project management across diverse stakeholder groups with competing priorities and different technical perspectives. This ability directly impacts project success rates and career advancement opportunities.

Beneficial Skills

LEAN Six Sigma expertise provides competitive advantage by demonstrating ability to optimize validation processes while maintaining compliance, leading to cost savings and efficiency improvements that enhance business performance Computer systems validation knowledge becomes increasingly valuable as manufacturing digitization accelerates, positioning professionals for leadership roles in digital transformation initiatives Risk assessment capabilities align with industry trends toward risk-based approaches to validation, enabling more strategic and resource-efficient validation strategies that deliver better business outcomes

Unique Aspects

The combination of process validation, method validation, and computerized systems validation creates a comprehensive role that provides exposure to multiple aspects of pharmaceutical manufacturing and quality systems
Direct involvement with external vendor management provides valuable commercial experience and supply chain understanding that enhances career versatility
The emphasis on LEAN Six Sigma tools indicates a progressive approach to quality management that combines regulatory compliance with operational excellence methodologies
Cross-functional team leadership responsibilities provide management experience and business acumen development opportunities typically reserved for more senior roles

Career Growth

Progression to senior individual contributor roles typically occurs within 2-3 years, with management opportunities available within 4-6 years depending on leadership development and business needs

Potential Next Roles

Senior Validation Engineer with expanded project leadership responsibilities Validation Manager overseeing validation teams and strategies Quality Assurance Manager with broader quality system oversight Regulatory Affairs specialist focusing on submission activities

Company Overview

ICDS Recruitment Consultants

ICDS Recruitment Consultants operates as a specialized recruitment firm serving the pharmaceutical, medical device, and life sciences sectors in Ireland, leveraging deep industry knowledge to connect technical professionals with leading multinational corporations and growing indigenous companies

Established recruitment partner with strong relationships across Ireland's life sciences ecosystem, particularly in the pharmaceutical and medical device manufacturing sectors that represent significant portions of Ireland's industrial base
This Waterford-based position likely serves major pharmaceutical manufacturing operations in the South East region, including established facilities from global companies that have made significant investments in Irish manufacturing capabilities
Recruitment consultant placement typically indicates structured corporate environments with established career development pathways, professional training opportunities, and exposure to international quality standards and best practices
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