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Laboratory Validation Engineer - Job Opportunity at Dillon Engineering Services

Westport, Ireland
Contract
Mid-level
Posted: August 1, 2025
On-site
€35-€40 per hour

Key Responsibilities

Lead strategic implementation of Site Validation Master Plan across multiple validation methodologies, directly impacting pharmaceutical product quality and regulatory compliance
Drive validation excellence for new equipment and process changes, ensuring seamless integration with existing manufacturing operations while maintaining GMP standards
Serve as primary validation liaison across departments, facilitating cross-functional collaboration and ensuring validation projects align with business objectives and regulatory timelines
Execute comprehensive documentation review and approval processes that safeguard against regulatory violations and support successful audit outcomes
Coordinate multi-disciplinary validation teams to deliver complex projects on schedule, optimizing resource allocation and minimizing operational disruptions
Conduct critical risk assessments and design reviews that influence major business decisions and prevent costly validation failures
Generate actionable insights through weekly metrics monitoring across quality management systems, driving data-driven improvements in validation processes
Support high-stakes regulatory submissions and Product Quality Reviews that directly impact market authorization and commercial success
Lead audit preparation and response activities, protecting company reputation and ensuring continued regulatory standing
Champion continuous improvement initiatives that enhance departmental efficiency and contribute to site-wide quality excellence

Requirements

Education

Bachelor's degree in a science-based or engineering discipline

Experience

Experience in a pharmaceutical or GMP-regulated environment

Required Skills

Strong project management and organisational skills Proficient in Microsoft Office applications Strong problem-solving and critical thinking abilities Clear and effective communication skills, both verbal and written Proven ability to manage conflict and navigate challenging situations Subject matter expertise in one or more areas such as Equipment, Facility, Aseptic Processes, Process Validation, Continued Process Verification (CPV), Computer System Validation (CSV), or Cleaning Validation
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Sauge AI Market Intelligence

Industry Trends

The pharmaceutical industry is experiencing unprecedented regulatory scrutiny, with validation engineers becoming critical gatekeepers for compliance as agencies like the FDA and EMA increase inspection frequency and severity of enforcement actions. This trend is driving significant demand for experienced validation professionals who can navigate complex regulatory landscapes while maintaining operational efficiency. Digital transformation in pharmaceutical manufacturing is creating new validation challenges and opportunities, particularly around computerized systems validation (CSV) and data integrity requirements. Companies are investing heavily in validation expertise to support their digital initiatives while ensuring compliance with evolving regulatory guidance on electronic records and signatures. The shift toward continuous manufacturing and real-time release testing in pharmaceuticals is revolutionizing validation approaches, with increased emphasis on Continued Process Verification (CPV) and risk-based validation strategies. This evolution requires validation engineers who can adapt traditional validation methodologies to support more agile manufacturing paradigms.

Salary Evaluation

The hourly rate of €35-40 is competitive for the Irish pharmaceutical market, translating to approximately €72,800-83,200 annually for full-time equivalent work. This positioning reflects the specialized nature of validation engineering and Ireland's status as a major pharmaceutical manufacturing hub, though it may be slightly below rates for permanent positions with equivalent responsibilities.

Role Significance

Typical validation teams in pharmaceutical facilities of this scale range from 5-12 professionals, with this role likely coordinating 2-4 junior validation specialists while reporting to a Senior Validation Manager or Quality Director. The position involves substantial cross-functional interaction with manufacturing, quality assurance, regulatory affairs, and engineering teams.
This mid-level position carries significant operational responsibility with direct impact on product quality and regulatory compliance. The role sits at a critical juncture between technical execution and strategic oversight, requiring independent decision-making on validation approaches while collaborating with senior leadership on risk assessments and regulatory strategy.

Key Projects

Equipment qualification projects for new analytical instruments and manufacturing equipment, involving Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols Process validation studies for drug substance and drug product manufacturing processes, including statistical analysis of process performance and establishment of proven acceptable ranges Computer system validation projects for laboratory information management systems (LIMS), manufacturing execution systems (MES), and other GxP-critical applications Cleaning validation programs to demonstrate effective removal of product residues and cleaning agents from manufacturing equipment Method validation and transfer activities supporting analytical testing procedures and ensuring data reliability across multiple laboratory sites

Success Factors

Deep understanding of regulatory requirements across multiple jurisdictions (FDA, EMA, HPRA) combined with practical application skills to translate regulatory guidance into actionable validation strategies that meet both compliance and business objectives Strong project management capabilities with proven ability to coordinate complex, multi-disciplinary validation projects while managing competing priorities, resource constraints, and tight regulatory timelines Technical expertise in multiple validation disciplines (equipment, process, cleaning, computer systems) enabling versatile contribution across diverse validation challenges and providing valuable cross-functional perspective Exceptional documentation and communication skills essential for creating defensible validation protocols, reports, and regulatory submissions that withstand scrutiny during inspections and audits Risk assessment and problem-solving capabilities that enable proactive identification of validation challenges, development of mitigation strategies, and rapid resolution of validation deviations or failures

Market Demand

High demand driven by Ireland's position as a global pharmaceutical manufacturing center, with companies like Pfizer, Johnson & Johnson, and numerous biotech firms requiring constant validation support for facility expansions, process improvements, and regulatory compliance initiatives.

Important Skills

Critical Skills

GMP and regulatory compliance expertise represents the foundational requirement for success, as any gaps in regulatory knowledge can result in validation failures, regulatory citations, and significant business impact. The multi-jurisdictional nature (HPRA, FDA, EMA) demands comprehensive understanding of varying regulatory expectations and the ability to develop validation strategies that satisfy the most stringent requirements across all applicable jurisdictions. Project management and organizational skills are absolutely essential given the complex, multi-disciplinary nature of validation projects involving coordination across manufacturing, quality, engineering, and regulatory functions. Strong project management ensures validation activities stay on schedule, within budget, and meet all deliverable requirements while managing stakeholder expectations and resolving conflicts that inevitably arise during validation execution. Documentation and communication capabilities are critical success factors as validation work is heavily documentation-dependent and subject to regulatory scrutiny. The ability to create clear, defensible validation protocols and reports while communicating complex technical concepts to diverse audiences (from technicians to senior management to regulatory inspectors) directly impacts validation success and regulatory compliance.

Beneficial Skills

Advanced statistical analysis capabilities for process validation and continued process verification activities, as the industry moves toward more sophisticated data analysis approaches for demonstrating process control and capability Computer system validation (CSV) expertise is increasingly valuable as pharmaceutical manufacturing becomes more digitized, with companies requiring validation support for manufacturing execution systems, laboratory information management systems, and emerging technologies like artificial intelligence and machine learning applications Change control and configuration management skills that support validation throughout the product lifecycle, ensuring validated states are maintained as equipment, processes, and systems evolve to meet changing business needs and regulatory requirements

Unique Aspects

The role combines traditional validation engineering with emerging areas like Continued Process Verification (CPV), positioning the successful candidate at the forefront of evolving pharmaceutical validation practices and providing valuable exposure to next-generation validation approaches
Direct involvement in risk assessments and design reviews across business units offers unusual breadth of exposure for a mid-level position, providing strategic perspective typically reserved for more senior roles and accelerating professional development
The emphasis on multiple validation disciplines (equipment, facility, aseptic processes, CSV, cleaning validation) creates opportunities for rapid skill diversification and increased market value as a versatile validation professional
Contract structure through a specialized pharmaceutical recruiter provides networking opportunities and potential access to subsequent high-quality assignments within Ireland's pharmaceutical sector, building a diverse portfolio of validation experience

Career Growth

Career progression to senior roles typically occurs within 3-5 years with demonstrated success in project delivery and regulatory compliance. Management positions generally require 5-8 years of total validation experience plus proven leadership capabilities.

Potential Next Roles

Senior Validation Engineer positions with expanded project leadership responsibilities and mentoring duties, typically involving oversight of multiple validation programs and strategic input on departmental initiatives Validation Manager roles overseeing entire validation departments, including budget responsibility, team leadership, and strategic planning for validation activities across multiple product lines or facilities Regulatory Affairs positions leveraging validation expertise to support regulatory submissions, agency interactions, and compliance strategy development Quality Assurance leadership roles such as QA Manager or Director positions, where validation background provides valuable perspective on overall quality system management

Company Overview

Dillon Engineering Services

Dillon Engineering Services operates as a specialized recruitment and staffing firm serving the pharmaceutical and biotechnology sectors in Ireland. The company has established itself as a key intermediary connecting skilled professionals with leading pharmaceutical manufacturers, leveraging deep industry knowledge and extensive networks built over years of focused sector engagement.

As a specialized recruiter in Ireland's thriving pharmaceutical sector, Dillon Engineering Services benefits from the country's position as a global pharmaceutical manufacturing hub. The firm competes in a dynamic market alongside both international staffing giants and boutique specialist recruiters, differentiating through sector expertise and local market knowledge.
This Westport-based assignment reflects the significant pharmaceutical manufacturing presence in the west of Ireland, with major facilities operated by global pharmaceutical companies. The location offers access to a skilled workforce while providing lower operating costs compared to Dublin, making it an attractive base for pharmaceutical operations.
Contract positions through specialized recruiters typically offer exposure to diverse pharmaceutical environments and validation challenges, providing accelerated learning opportunities and broad industry networking. The 6-month timeframe suggests either project-specific requirements or potential for extension based on performance and business needs.
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