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Quality Validation Engineer - Job Opportunity at Collins McNicholas Recruitment

Waterford, Ireland
Full-time
Mid-level
Posted: July 10, 2025
On-site
€50,000–€55,000 per year

Benefits

Comprehensive company pension scheme providing long-term financial security and retirement planning support
Employee assistance program offering confidential counseling and support services for personal and professional challenges

Key Responsibilities

Develop and execute critical validation documentation ensuring regulatory compliance with HPRA and FDA requirements, directly impacting product market approval and company reputation
Lead cross-functional validation initiatives that drive operational excellence and support strategic business objectives across manufacturing processes
Establish validation frameworks for injection molding and assembly processes that ensure product quality and manufacturing efficiency
Coordinate with external vendors to optimize validation requirements and maintain supply chain quality standards
Drive GMP compliance initiatives that protect company operations and maintain regulatory standing in healthcare markets
Execute risk assessment protocols for regulated processes, safeguarding product integrity and patient safety
Lead quality audits and implement LEAN Six Sigma methodologies to optimize operational performance and reduce manufacturing costs

Requirements

Education

Degree in Engineering/Science discipline

Experience

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

Required Skills

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 of LEAN 6 sigma tools for problem solution Ideally knowledge of process validation and capability Experience in method validation and process characterization is an advantage
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Sauge AI Market Intelligence

Industry Trends

The pharmaceutical and medical device manufacturing sector in Ireland is experiencing unprecedented growth, driven by the country's position as a global hub for life sciences companies. This growth is creating substantial demand for validation engineers who can navigate complex regulatory requirements while maintaining operational efficiency. The sector is particularly focused on advanced manufacturing processes including injection molding and assembly automation, requiring professionals who understand both traditional validation principles and emerging digital validation technologies. Regulatory requirements are becoming increasingly stringent across global markets, with harmonization efforts between FDA, EMA, and other regulatory bodies creating new compliance challenges. Companies are investing heavily in validation capabilities to ensure market access and maintain competitive advantage, particularly in the post-Brexit environment where Irish facilities serve as critical EU manufacturing bases for multinational pharmaceutical companies. The integration of Industry 4.0 technologies and digital validation approaches is transforming traditional validation practices. Companies are seeking validation engineers who can bridge traditional GMP requirements with modern data analytics, continuous monitoring systems, and risk-based validation approaches that optimize both compliance and operational efficiency.

Salary Evaluation

The offered salary of €50,000-€55,000 represents a competitive market rate for mid-level validation engineers in Ireland's pharmaceutical sector. This range aligns well with current market conditions, considering Ireland's strong life sciences presence and the specialized nature of medical device validation. The salary positioning suggests good growth potential and reflects the strategic importance of validation roles in maintaining regulatory compliance.

Role Significance

Typically operates within a quality team of 5-10 professionals, with direct collaboration across manufacturing, regulatory affairs, and operations departments. The role involves coordinating with external vendors and regulatory agencies, suggesting a network of 15-20 regular professional contacts.
This is a mid-level position with significant strategic impact, requiring independent decision-making capabilities and cross-functional leadership. The role involves direct responsibility for regulatory compliance and quality systems that affect product approval and market access, indicating substantial organizational trust and accountability.

Key Projects

Implementation of comprehensive validation programs for new product launches and manufacturing process transfers Development of master validation plans supporting facility expansion and capability enhancement initiatives Cross-functional quality improvement projects utilizing LEAN Six Sigma methodologies to optimize manufacturing efficiency Regulatory audit preparation and response activities ensuring continued compliance with evolving international standards

Success Factors

Deep understanding of pharmaceutical and medical device regulations combined with practical application experience in manufacturing environments Strong technical writing and documentation skills essential for creating validation protocols that satisfy both internal standards and regulatory requirements Cross-functional collaboration capabilities enabling effective coordination between quality, manufacturing, regulatory, and external stakeholder groups Analytical problem-solving skills supported by LEAN Six Sigma training for continuous improvement initiatives Adaptability to evolving regulatory requirements and ability to implement new validation approaches while maintaining operational efficiency

Market Demand

High demand driven by Ireland's position as a European pharmaceutical manufacturing hub and increasing regulatory complexity requiring specialized validation expertise

Important Skills

Critical Skills

Regulatory knowledge of EudraLex, ISO13485, ISO14644, GAMP5, and FDA requirements is absolutely essential as these standards govern all validation activities and directly impact product approval and market access. Without this foundation, the role cannot be performed effectively, and companies face significant regulatory risks. Technical writing capabilities are crucial for creating validation protocols, reports, and documentation that must satisfy both internal quality standards and regulatory agency requirements. Poor documentation can lead to regulatory delays, failed audits, and product recalls. Cross-functional collaboration skills are vital as validation engineers must coordinate with manufacturing, quality assurance, regulatory affairs, and external vendors to ensure successful validation outcomes. The ability to influence without direct authority is essential for driving validation initiatives across organizational boundaries.

Beneficial Skills

LEAN Six Sigma expertise provides valuable continuous improvement capabilities that help optimize validation processes and reduce operational costs while maintaining compliance standards Experience with digital validation technologies and data analytics tools will become increasingly important as the industry adopts Industry 4.0 approaches to validation and quality management Project management skills and experience with validation software systems will enhance effectiveness in coordinating complex validation projects and managing multiple concurrent initiatives

Unique Aspects

Opportunity to work with both injection molding and assembly processes in a healthcare manufacturing environment, providing diverse technical experience across multiple manufacturing technologies
Direct exposure to both FDA and EMA regulatory requirements, offering valuable international regulatory experience that enhances career mobility
Integration of LEAN Six Sigma methodologies with traditional validation practices, providing modern quality improvement skills highly valued in pharmaceutical manufacturing
Cross-functional team environment offering exposure to multiple aspects of pharmaceutical manufacturing and quality systems

Career Growth

Progression to senior validation roles typically occurs within 3-5 years with demonstrated expertise and leadership capabilities, while transition to management positions generally requires 5-7 years of progressive experience

Potential Next Roles

Senior Validation Engineer with expanded responsibility for validation strategy development and team leadership Quality Assurance Manager overseeing comprehensive quality systems and regulatory compliance programs Regulatory Affairs Specialist focusing on product registration and regulatory strategy development Manufacturing Quality Manager with responsibility for site-wide quality operations and continuous improvement

Company Overview

Collins McNicholas Recruitment

Collins McNicholas Recruitment is a well-established Irish recruitment consultancy specializing in pharmaceutical, medical device, and life sciences placements. The company has built strong relationships with leading multinational corporations and indigenous Irish companies across the life sciences sector, providing specialized recruitment services for technical and regulatory roles.

Recognized as a leading recruitment partner in Ireland's life sciences sector, with particular expertise in pharmaceutical manufacturing and medical device companies. The firm's focus on quality placements and long-term client relationships has established it as a trusted advisor for both companies and candidates in the specialized validation and quality engineering space.
The position is located in Waterford, Ireland's southeast region, which has emerged as a significant pharmaceutical and medical device manufacturing cluster. This location provides access to multiple multinational facilities while offering a lower cost of living compared to Dublin, making it an attractive option for career development in the life sciences sector.
The role involves working within an established healthcare manufacturing environment that emphasizes quality, compliance, and continuous improvement. The company culture likely prioritizes safety, regulatory excellence, and cross-functional collaboration, with strong emphasis on professional development and career advancement opportunities.
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