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Validation Engineer - Job Opportunity at PE Global

County Mayo, Ireland

Contract

Mid-level

Posted: July 3, 2025

On-site

EUR 45,000 - 60,000 per year for this contract position, with potential for higher compensation based on specialized expertise in biologics validation. The salary range reflects the specialized nature of pharmaceutical validation work in Ireland's competitive life sciences market, with contract positions typically commanding premium rates compared to permanent roles.

Key Responsibilities

Drive strategic validation initiatives across laboratory equipment, systems and processes to ensure operational excellence and regulatory compliance for critical biologics manufacturing operations

Lead cross-functional validation projects as the primary departmental liaison, coordinating with senior management and business units to deliver customer satisfaction through comprehensive validation strategies

Orchestrate site validation master plans encompassing prospective, concurrent, and retrospective validation studies, ensuring timely execution and compliance with global standards

Spearhead risk assessment processes across all business units and participate in design review processes to proactively identify and mitigate validation risks

Execute comprehensive documentation management for validation studies, ensuring all materials are compiled, authorized, and filed in accordance with corporate and regulatory expectations

Facilitate critical review processes including PQR reviews, regulatory reviews, and laboratory equipment reviews to maintain continuous compliance

Support audit preparation and response activities, serving as a key interface with internal and external auditing bodies

Generate and track weekly compliance metrics across multiple systems to provide visibility into validation performance and regulatory adherence

Requirements

Education

Bachelor's degree required in science based or engineering discipline

Experience

Experience in Pharmaceutical company

Required Skills

Excellent project management skills Proficient in use of Microsoft Office suite of programs Critical thinking and problem-solving skills Ability to articulate clearly when dealing with internal and external bodies Excellent conflict handling skills Expertise in the relevant subject matter areas – example Equipment, Facility, Aseptic, Process, CPV, CSV, Cleaning

Sauge AI Market Intelligence

Industry Trends

The biologics manufacturing sector is experiencing unprecedented growth driven by the expansion of biosimilar markets and innovative therapeutic developments, creating sustained demand for validation engineering expertise. Regulatory agencies are increasingly emphasizing data integrity and continuous monitoring, requiring validation engineers to adapt to more sophisticated compliance frameworks. The industry is moving toward integrated quality management systems that combine traditional validation approaches with digital transformation initiatives, creating opportunities for professionals who can bridge traditional pharmaceutical manufacturing with modern technology solutions. Ireland's position as a leading hub for pharmaceutical and biologics manufacturing continues to strengthen, with significant investments from multinational companies establishing or expanding operations. The country's skilled workforce, favorable regulatory environment, and strategic location for European market access make it an attractive destination for life sciences companies, driving consistent demand for validation engineering roles. The shift toward personalized medicine and advanced therapy medicinal products (ATMPs) is creating new validation challenges that require specialized expertise in novel manufacturing processes and regulatory frameworks. Companies are increasingly seeking validation engineers who can navigate the complexities of these emerging therapeutic areas while maintaining compliance with evolving regulatory standards.

Role Significance

Typically works within a validation team of 5-8 engineers, collaborating closely with quality assurance, manufacturing, and regulatory affairs departments. The role involves coordinating with multiple stakeholders across different business units, requiring strong interpersonal and project management skills to ensure effective cross-functional collaboration.

This role represents a mid-level position with significant autonomy and cross-functional leadership responsibilities. The validation engineer serves as a key technical expert and project coordinator, interfacing with senior management while guiding validation activities across multiple business units. The role combines hands-on technical work with strategic oversight, positioning the incumbent as a critical contributor to the organization's quality and compliance objectives.

Key Projects

Laboratory equipment qualification and validation projects for new and existing manufacturing systems Process validation studies for biologics manufacturing processes, including technology transfer and scale-up activities Computerized system validation (CSV) projects for laboratory information management systems and manufacturing execution systems Cleaning validation studies for multi-product manufacturing facilities Continuous process verification (CPV) programs for established manufacturing processes

Success Factors

Deep understanding of pharmaceutical regulations including FDA, EMA, and HPRA guidelines, with ability to interpret and apply regulatory requirements to practical validation scenarios Strong project management capabilities with experience managing multiple concurrent validation projects while maintaining quality standards and meeting regulatory timelines Excellent technical writing skills for creating comprehensive validation protocols, reports, and regulatory submissions that meet both internal and external quality standards Effective stakeholder management abilities to coordinate with cross-functional teams, manage conflicting priorities, and ensure alignment between validation activities and business objectives Continuous learning mindset to stay current with evolving regulatory guidance, industry best practices, and emerging technologies in pharmaceutical manufacturing and validation

Market Demand

High demand driven by Ireland's robust pharmaceutical manufacturing sector and the critical importance of validation engineering in ensuring product quality and regulatory compliance. The specialized nature of biologics validation creates particularly strong demand for experienced professionals who can navigate complex regulatory requirements.

Important Skills

Critical Skills

Project management expertise is absolutely essential given the complex, multi-stakeholder nature of validation projects that must be delivered within strict regulatory timelines while coordinating resources across multiple functional areas. Strong project management capabilities directly impact the success of validation initiatives and the organization's ability to meet regulatory commitments and business objectives. Deep technical knowledge of validation methodologies and regulatory requirements forms the foundation of effective validation engineering practice. This includes understanding of equipment qualification, process validation, cleaning validation, and computerized system validation principles, as well as familiarity with regulatory frameworks from FDA, EMA, and other relevant authorities. Excellent communication and conflict resolution skills are critical for navigating the complex stakeholder environment typical of pharmaceutical validation projects. The ability to clearly articulate technical concepts to diverse audiences and manage competing priorities ensures successful project outcomes and stakeholder satisfaction.

Beneficial Skills

Experience with digital validation tools and electronic documentation systems is increasingly valuable as the industry moves toward paperless validation and integrated quality management systems. Familiarity with these technologies can significantly enhance efficiency and career prospects in modern pharmaceutical manufacturing environments. Knowledge of emerging regulatory frameworks for advanced therapy medicinal products (ATMPs) and personalized medicine manufacturing provides competitive advantage as these therapeutic areas continue to grow. Understanding of these specialized validation requirements positions professionals for roles in cutting-edge pharmaceutical development and manufacturing.

Unique Aspects

Specialized focus on biologics validation presents unique technical challenges and regulatory considerations compared to traditional pharmaceutical manufacturing, offering exposure to cutting-edge biotechnology processes and manufacturing systems

Six-month contract duration provides opportunity for rapid skill development and exposure to concentrated validation projects, potentially leading to permanent opportunities or enhanced marketability for subsequent roles

Location in Mayo offers access to Ireland's growing pharmaceutical manufacturing cluster while providing quality of life benefits associated with Ireland's western regions

Direct involvement in regulatory review processes and audit activities provides valuable experience in regulatory affairs and compliance management that enhances career versatility

Career Growth

Career progression typically occurs within 2-3 years for high-performing individuals, with advancement opportunities depending on the acquisition of additional technical expertise, leadership experience, and successful project delivery track record.

Potential Next Roles

Senior Validation Engineer with expanded technical leadership responsibilities and oversight of junior validation staff Validation Manager responsible for leading validation teams and developing departmental strategies and procedures Quality Assurance Manager with broader responsibility for quality systems and regulatory compliance across multiple functional areas Regulatory Affairs Specialist focusing on validation-related regulatory submissions and agency interactions

Company Overview

PE Global

PE Global operates as a specialized recruitment consultancy serving the life sciences and pharmaceutical sectors, with particular expertise in placing technical professionals in Ireland's thriving pharmaceutical manufacturing industry. The company has established strong relationships with leading multinational pharmaceutical companies and provides both permanent and contract staffing solutions across various technical disciplines.

PE Global maintains a strong position in the Irish pharmaceutical recruitment market, leveraging deep industry knowledge and established client relationships to connect qualified professionals with leading pharmaceutical companies. The company's focus on technical specialization and industry expertise has enabled it to build a reputation for quality placements in the competitive life sciences sector.

This role demonstrates PE Global's strong presence in Ireland's pharmaceutical corridor, particularly in the western regions where major pharmaceutical and biologics manufacturers have established significant operations. The Mayo location reflects the company's ability to serve clients across Ireland's distributed pharmaceutical manufacturing base.

The contract nature of this position reflects the dynamic and project-driven culture typical of pharmaceutical manufacturing environments, where validation activities are often tied to specific regulatory timelines and business objectives. The role offers exposure to cutting-edge biologics manufacturing processes while providing the flexibility and variety that comes with contract-based technical work.

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Validation Engineer - Job Opportunity at PE Global

Key Responsibilities

Requirements

Education

Experience

Required Skills

Sauge AI Market Intelligence

Industry Trends

Role Significance

Key Projects

Success Factors

Market Demand

Important Skills

Critical Skills

Beneficial Skills

Unique Aspects

Career Growth

Potential Next Roles

Company Overview

PE Global

Data Sources & Analysis Information

Job Listings Data

Sauge AI Market Intelligence