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Product Quality Engineer – Visual Inspection (Pharma) - Job Opportunity at GerTEK Project Management and Technical Services

Sligo, Ireland
Full-time
Mid-level
Posted: August 25, 2025
On-site
EUR 55,000 - EUR 75,000 per year based on Ireland's competitive pharmaceutical sector, the specialized nature of visual inspection engineering, and the mid-level experience requirements. Ireland's pharmaceutical industry offers premium compensation due to high demand for quality engineering talent and the critical nature of regulatory compliance roles.

Benefits

On-site work experience providing direct exposure to pharmaceutical manufacturing environments and regulatory compliance
Opportunity to work with world's largest life science and technology companies through GerTEK's established partnerships
Professional development through leading validation activities and cross-training responsibilities
Exposure to cutting-edge biotechnology and pharmaceutical manufacturing processes including fill-finish and lyophilization operations

Key Responsibilities

Drive visual inspection operations excellence while ensuring full compliance with safety, regulatory, and organizational standards that directly impact product quality and patient safety
Lead the development and optimization of manufacturing procedures that enhance operational efficiency and reduce quality risks
Spearhead process, equipment, and facilities validation initiatives that are critical for regulatory approval and commercial success
Execute comprehensive protocol reviews and approvals that ensure manufacturing readiness and regulatory compliance timelines
Establish and optimize technician certification processes that build organizational capability and ensure consistent quality standards
Create and maintain defect libraries that serve as critical knowledge assets for continuous improvement and regulatory submissions
Implement trending analysis systems for visual inspection defects that enable proactive quality management and risk mitigation
Ensure global-local alignment of visual inspection procedures that maintains consistency across international operations
Provide technical leadership for manufacturing and validation activities that directly impact project success and commercial timelines
Coordinate cross-functional stakeholder engagement for particle and defect evaluation that supports critical quality decisions
Lead technical transfer activities for new product introductions that enable successful market expansion
Drive investigation and resolution of process exceptions that protect product quality and manufacturing continuity

Requirements

Education

A relevant third level qualification in an engineering, science or technical discipline (Degree Level or Masters Preferable)

Experience

At least three (3) years of total combined experience in Technical/Operations/Operations/Quality or equivalent in a Pharmaceutical and Health Care Organization. At least three (3) years of experience in the manufacturing environment of a biotechnology, pharmaceutical or health care plant.

Required Skills

Manual Visual Inspection (MVI) of vials or syringes Manufacturing processes of biotechnological drugs Parenteral drugs manufacturing Solutions preparation Fill finish operations Lyophilisation Sterilisation operations Clean utilities Process FMEAs Protocol development and execution Technical transfer processes Cross-functional coordination Process exception investigation
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Sauge AI Market Intelligence

Industry Trends

The pharmaceutical industry is experiencing unprecedented growth in biologics and biosimilar manufacturing, driving increased demand for visual inspection expertise as these complex molecules require more sophisticated quality control measures. This trend is particularly strong in Ireland, which has become a major hub for pharmaceutical manufacturing with significant investments from global companies. Regulatory authorities including FDA and EMA are intensifying focus on visual inspection processes and defect detection capabilities, requiring companies to invest heavily in specialized engineering talent who can navigate complex validation requirements and ensure compliance across multiple jurisdictions. The shift toward personalized medicine and smaller batch sizes is creating demand for more flexible and adaptable visual inspection systems, requiring engineers who can optimize processes for varied production scales while maintaining stringent quality standards. Digital transformation in pharmaceutical manufacturing is driving integration of AI and machine learning with traditional visual inspection processes, creating opportunities for engineers who can bridge traditional quality control methods with emerging technologies.

Role Significance

Typically operates within a quality engineering team of 5-8 professionals, collaborating closely with manufacturing operations teams of 15-25 technicians and operators, plus regular interaction with validation, regulatory affairs, and technical services teams totaling 30-50 cross-functional colleagues.
This is a mid-level individual contributor role with significant technical leadership responsibilities and cross-functional influence. The position carries substantial accountability for quality systems and regulatory compliance, indicating high organizational trust and impact despite not having direct reports.

Key Projects

Leading comprehensive visual inspection system validations for new product launches worth millions in potential revenue Implementing defect trending and analysis systems that support continuous improvement initiatives and regulatory submissions Managing technical transfer projects for product introductions that enable market expansion and competitive positioning Developing and optimizing technician certification programs that build organizational capability and ensure consistent quality delivery across shifts and campaigns

Success Factors

Deep understanding of pharmaceutical regulatory requirements and validation principles, as the role requires navigating complex compliance landscapes while maintaining operational efficiency and supporting business objectives in a highly regulated industry environment. Strong project management and cross-functional collaboration skills, as success depends on coordinating with multiple internal and external stakeholders, managing competing priorities, and driving results through influence rather than direct authority in a matrix organization structure. Technical expertise in visual inspection methodologies and defect analysis, combined with the ability to translate complex technical concepts into actionable procedures and training materials that can be effectively implemented by manufacturing teams with varying technical backgrounds. Continuous improvement mindset and analytical thinking capabilities, as the role requires identifying trends, investigating exceptions, and implementing systematic solutions that enhance quality outcomes while supporting operational efficiency and regulatory compliance goals.

Market Demand

Very High - Ireland's position as a global pharmaceutical manufacturing hub, combined with the specialized nature of visual inspection engineering and increasing regulatory requirements, creates strong demand for qualified professionals in this field.

Important Skills

Critical Skills

Manual Visual Inspection expertise is absolutely essential as it forms the core technical competency for the role, requiring deep understanding of defect identification, classification, and trending analysis that directly impacts product quality and regulatory compliance in pharmaceutical manufacturing environments. Process validation and protocol development capabilities are critical for success, as the role requires designing and executing comprehensive validation strategies that ensure manufacturing readiness, regulatory approval, and commercial success while managing complex technical and business requirements. Cross-functional collaboration and stakeholder management skills are essential given the role's requirement to coordinate with internal and external partners, influence without authority, and drive consensus across diverse technical and business teams with competing priorities and perspectives.

Beneficial Skills

Digital quality systems and data analysis capabilities are increasingly valuable as the pharmaceutical industry adopts advanced analytics and digital technologies for quality monitoring, trend analysis, and predictive quality management that enhance traditional visual inspection processes. Regulatory affairs knowledge and international compliance expertise provide significant advantage given the global nature of pharmaceutical operations and the complexity of navigating multiple regulatory jurisdictions with varying requirements and expectations for visual inspection processes. Project management and change management skills offer substantial career advancement potential as pharmaceutical companies increasingly value technical professionals who can lead complex initiatives, manage organizational change, and drive strategic improvements across manufacturing operations.

Unique Aspects

This role offers exceptional exposure to world-class pharmaceutical manufacturing operations through GerTEK's partnerships with industry leaders, providing accelerated learning opportunities and professional network development that would typically take years to achieve in a single company environment.
The position combines hands-on technical work with strategic responsibility for establishing and optimizing critical quality systems, offering a unique blend of operational expertise and systems thinking that is highly valuable for career advancement in pharmaceutical quality roles.
Working in Ireland's pharmaceutical hub provides access to cutting-edge manufacturing technologies and regulatory approaches, as Ireland serves as a European gateway for many global pharmaceutical companies implementing their most advanced manufacturing strategies.
The role offers direct involvement in technical transfer and new product introduction activities, providing exposure to commercial decision-making and strategic planning processes that extend beyond traditional quality engineering scope and enhance business acumen development.

Career Growth

Typical progression to senior individual contributor or first-level management roles occurs within 3-5 years, with advancement to director-level positions possible within 6-8 years for high performers who develop strong business acumen and leadership capabilities alongside their technical expertise.

Potential Next Roles

Senior Quality Engineer or Quality Engineering Manager positions leading larger teams and more complex validation projects within 3-5 years, with responsibility for multiple product lines and strategic quality initiatives Validation Manager or Technical Services Manager roles overseeing comprehensive validation programs and technical support functions across entire manufacturing sites within 4-6 years Quality Assurance Director or Plant Quality Manager positions with full accountability for site quality systems and regulatory compliance within 5-8 years, including P&L responsibility and strategic planning

Company Overview

GerTEK Project Management and Technical Services

GerTEK Project Management and Technical Services operates as a specialized engineering consultancy serving the life sciences sector, with particular strength in commissioning, qualification, and validation services. The company has established itself as a trusted partner for major pharmaceutical and biotechnology companies, focusing on delivering critical project management and technical expertise for complex manufacturing and facility projects.

GerTEK holds a strong position in the Irish and European pharmaceutical services market, particularly in the commissioning and validation space. Their partnerships with world-leading life science companies indicate solid industry recognition and repeat business relationships, suggesting competitive differentiation in technical expertise and project delivery capabilities.
Operating from Ireland positions GerTEK strategically within one of Europe's most important pharmaceutical manufacturing hubs, providing access to major multinational clients and complex projects. Ireland's role as a European headquarters location for many pharmaceutical companies offers significant opportunities for business development and technical specialization.
As a specialized consultancy, GerTEK likely emphasizes technical excellence, client service, and project delivery within a collaborative, knowledge-sharing environment. The company culture probably values continuous learning and professional development, given the rapidly evolving regulatory landscape and the need to maintain cutting-edge expertise across multiple client environments.
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