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Manufacturing 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 mid-level pharmaceutical engineering roles in Ireland, with potential for higher compensation given the specialized nature of visual inspection expertise and the strong pharmaceutical sector presence in the region

Benefits

Opportunity to work with world's largest life science and technology companies providing exposure to cutting-edge pharmaceutical manufacturing processes
Access to strategic and high-impact projects that enhance professional portfolio and industry reputation
Professional development through cross-training responsibilities and project leadership opportunities
Exposure to global guidance documents and regulatory frameworks enhancing regulatory expertise
Collaboration with internal and external stakeholders building extensive professional network

Key Responsibilities

Lead critical visual inspection operations ensuring pharmaceutical product quality and patient safety compliance across all regulatory frameworks
Drive manufacturing excellence through development and optimization of procedures that directly impact production efficiency and quality outcomes
Spearhead validation efforts for processes, equipment, and facilities ensuring seamless project implementations and regulatory compliance
Execute strategic protocol reviews and approvals with accountability for completeness, accuracy, and adherence to project timelines
Champion Process FMEA initiatives for Visual Inspection operations identifying and mitigating critical quality risks
Establish and optimize technician certification processes ensuring consistent quality standards and operational excellence
Build and maintain comprehensive defect libraries serving as critical quality reference systems for manufacturing operations
Implement trending analysis processes for Visual Inspection defects enabling proactive quality improvements and risk mitigation
Ensure global alignment of site procedures with regulatory requirements maintaining compliance across international standards
Provide technical leadership in SOP development directly influencing manufacturing protocols and quality standards
Lead cross-functional manufacturing and validation activities throughout complete project lifecycles from conception to implementation
Coordinate stakeholder evaluations for particles and defects ensuring rapid resolution and quality maintenance
Facilitate technical transfers for new product introductions ensuring seamless integration and optimal manufacturing outcomes
Drive root cause analysis for process exceptions and incidents maintaining manufacturing integrity and continuous improvement
Partner with engineering and quality personnel fostering collaborative problem-solving and knowledge sharing
Support production teams in achieving output and yield targets through process optimization and technical guidance

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. Manual Visual Inspection (MVI) of vials or syringes: 2 years (preferred)

Required Skills

Previous experience in manufacturing processes of biotechnological drugs parenteral drugs solutions preparation fill finish Lyophilisation sterilisation operations Experience in clean utilities
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Sauge AI Market Intelligence

Industry Trends

The pharmaceutical industry is experiencing unprecedented growth in biologics and biosimilar manufacturing, driving demand for specialized visual inspection engineers who can ensure product quality in complex manufacturing environments. This trend is particularly strong in Ireland, which has become a major hub for pharmaceutical manufacturing with significant investments from global companies. Regulatory compliance requirements are becoming increasingly stringent globally, with agencies like the FDA and EMA demanding more sophisticated quality control processes. Visual inspection engineers with experience in validation and regulatory frameworks are becoming critical assets for pharmaceutical companies navigating these complex requirements. The shift towards personalized medicine and smaller batch sizes is increasing the importance of flexible manufacturing processes and robust visual inspection systems. Engineers who can adapt processes quickly while maintaining quality standards are in high demand across the pharmaceutical sector.

Role Significance

Typically works within a quality assurance or manufacturing engineering team of 8-15 professionals, with extensive cross-functional collaboration across production, quality, validation, and external contractor teams
Mid-level individual contributor role with significant technical leadership responsibilities, operating with substantial autonomy while reporting to senior management. The position carries high accountability for quality outcomes and regulatory compliance, indicating strong organizational trust and technical expertise requirements.

Key Projects

Large-scale equipment and facility validation projects for new pharmaceutical manufacturing lines Implementation of global quality standards and harmonization of visual inspection processes across multiple sites Technology transfer projects for new product introductions requiring comprehensive process validation and defect analysis Regulatory compliance initiatives involving FDA, EMA, and other international health authority inspections and submissions

Success Factors

Deep technical expertise in pharmaceutical manufacturing processes combined with strong regulatory knowledge enables effective navigation of complex compliance requirements while maintaining operational efficiency Proven ability to lead cross-functional projects and manage multiple stakeholders simultaneously, as the role requires coordination between internal teams, external contractors, and regulatory bodies Strong analytical and problem-solving capabilities for root cause analysis of manufacturing issues and development of sustainable corrective actions Excellent communication skills for training technicians, developing procedures, and interfacing with quality and engineering personnel across different organizational levels Adaptability and continuous learning mindset to keep pace with evolving regulatory requirements and emerging pharmaceutical manufacturing technologies

Market Demand

High demand driven by Ireland's position as a major pharmaceutical manufacturing hub and the critical importance of visual inspection in ensuring drug product quality and regulatory compliance

Important Skills

Critical Skills

Visual inspection expertise in pharmaceutical manufacturing is absolutely essential as this represents the core technical competency for the role. The ability to identify defects, establish defect libraries, and train technicians directly impacts product quality and patient safety, making this the most crucial skill for success. Regulatory compliance knowledge and validation experience are critical given the heavily regulated nature of pharmaceutical manufacturing. Understanding FDA, EMA, and ICH guidelines enables effective protocol development and ensures manufacturing operations meet international standards. Process engineering fundamentals in pharmaceutical manufacturing provide the technical foundation needed to optimize manufacturing operations, troubleshoot issues, and implement improvements while maintaining quality and compliance standards.

Beneficial Skills

Project management capabilities would enhance effectiveness in leading validation activities and coordinating cross-functional teams throughout project lifecycles Data analysis and statistical process control skills would strengthen defect trending capabilities and enable more sophisticated quality improvements Change management and training development expertise would support the technician certification responsibilities and procedure implementation across manufacturing teams International regulatory knowledge beyond FDA and EMA would be valuable for companies with global manufacturing footprints and diverse market requirements

Unique Aspects

Opportunity to work across multiple world-class pharmaceutical companies through GerTEK's consultancy model, providing broader industry exposure than typical single-company roles
Focus on visual inspection engineering represents a highly specialized niche within pharmaceutical manufacturing, offering deep technical expertise development in a critical quality control area
Direct involvement in strategic projects for global pharmaceutical companies, providing visibility into industry best practices and emerging technologies
Combination of technical engineering responsibilities with validation and regulatory compliance expertise creates a comprehensive skill set highly valued in the pharmaceutical industry

Career Growth

Typical progression to senior roles within 3-5 years with strong performance, or transition to management positions within 5-7 years depending on leadership development and organizational needs

Potential Next Roles

Senior Manufacturing Engineer with expanded scope across multiple product lines and manufacturing areas Validation Manager overseeing comprehensive qualification and validation programs Quality Assurance Manager responsible for site-wide quality systems and regulatory compliance Technical Operations Manager with P&L responsibility for manufacturing operations

Company Overview

GerTEK Project Management and Technical Services

GerTEK Project Management and Technical Services operates as a specialized engineering consultancy firm serving the life sciences and technology sectors. The company focuses on providing project management, talent solutions, and commissioning qualification and validation services to major pharmaceutical and biotechnology companies globally.

Well-positioned niche consultancy with established relationships among major life science companies, leveraging Ireland's strategic location and strong pharmaceutical manufacturing ecosystem to deliver specialized technical services
Strong presence in Ireland's pharmaceutical corridor with the Sligo location providing access to both domestic and international pharmaceutical manufacturing operations, benefiting from Ireland's favorable business environment and skilled workforce
Professional consultancy environment emphasizing technical excellence, client service, and project delivery, with exposure to diverse pharmaceutical companies and cutting-edge manufacturing technologies through client partnerships
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