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Visual Inspection Engineer (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 - 70,000 annually based on Ireland's competitive pharmaceutical sector compensation levels, mid-level engineering requirements, and Sligo's cost of living. The specialized nature of visual inspection engineering in sterile manufacturing typically commands premium compensation within the pharmaceutical engineering salary range.

Key Responsibilities

Lead cross-functional teams in supporting critical Visual Inspection operations ensuring compliance with stringent safety, regulatory and organizational requirements that directly impact product quality and patient safety
Drive operational excellence through development and modification of manufacturing procedures that optimize Visual Inspection processes and support continuous improvement initiatives
Execute strategic validation efforts for process, equipment, and facilities that ensure regulatory compliance and enable successful product launches in global markets
Provide technical leadership in reviewing and approving commissioning, qualification and validation protocols, ensuring accuracy and completeness that prevents costly delays and regulatory issues
Manage complex project timelines through timely protocol execution, coordinating multiple stakeholders to meet critical manufacturing milestones
Lead Process FMEA initiatives for Visual Inspection operations, identifying and mitigating risks that could impact product quality or manufacturing efficiency
Establish and optimize technician certification processes that ensure consistent quality standards and maintain regulatory compliance across manufacturing operations
Build and maintain comprehensive defect libraries that serve as critical knowledge repositories for quality decision-making and regulatory submissions
Implement trending analysis processes for Visual Inspection defects that enable proactive quality improvements and reduce manufacturing risks
Ensure alignment between site procedures and global guidance documents, maintaining regulatory compliance across multiple jurisdictions
Provide strategic technical input for SOP development that standardizes best practices and ensures consistent quality outcomes
Lead manufacturing and validation activities throughout project lifecycles, ensuring successful technology transfers and product introductions
Coordinate with internal and external stakeholders for particle and defect evaluation, building partnerships that enhance technical capabilities
Drive technical transfer activities for new product introductions, ensuring seamless integration into existing manufacturing operations
Investigate and resolve process exceptions and incidents, implementing corrective actions that prevent recurrence and improve system reliability
Partner with cross-functional teams including Engineering and Quality personnel to optimize manufacturing processes and achieve output targets

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

Previous experience in manufacturing processes of biotechnological drugs parenteral drugs solutions preparation fill finish Lyophilisation sterilisation operations Experience in clean utilities Manual Visual Inspection (MVI) of vials or syringes
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Sauge AI Market Intelligence

Industry Trends

The pharmaceutical industry is experiencing unprecedented growth in biologics and sterile injectable manufacturing, driving significant demand for visual inspection expertise as regulatory agencies increase scrutiny on particulate matter and container closure integrity. This trend is particularly pronounced in Ireland, which has become a global hub for pharmaceutical manufacturing with over 120 companies operating in the country. Digital transformation and Industry 4.0 initiatives are revolutionizing visual inspection processes, with companies investing heavily in automated inspection systems, artificial intelligence, and machine learning technologies. However, regulatory requirements still mandate human oversight and manual inspection capabilities, creating a hybrid approach that requires engineers skilled in both traditional and advanced inspection methodologies. Post-Brexit pharmaceutical supply chain restructuring has intensified focus on European manufacturing capabilities, particularly in Ireland, leading to increased investment in facility expansions and new product introductions that require specialized visual inspection engineering expertise.

Role Significance

Typically manages cross-functional project teams of 5-15 members including technicians, quality specialists, and validation personnel, while collaborating with broader manufacturing teams of 50+ employees across multiple departments.
Mid-level professional role with significant technical leadership responsibilities, operating with substantial autonomy while reporting to senior management. The position requires independent decision-making on critical quality and compliance matters that directly impact manufacturing operations and regulatory standing.

Key Projects

Implementation of new visual inspection systems for product launches Process validation and qualification projects for sterile manufacturing lines Technology transfer initiatives for global product portfolio expansions Regulatory compliance upgrades and facility modernization projects Cross-site standardization of visual inspection procedures and training programs

Success Factors

Deep understanding of pharmaceutical regulatory requirements including FDA, EMA, and ICH guidelines for sterile manufacturing and visual inspection, combined with practical experience in implementing compliant processes that withstand regulatory scrutiny. Strong technical leadership capabilities to manage complex validation projects involving multiple stakeholders, tight timelines, and high-stakes regulatory outcomes that directly impact product approvals and market access. Expertise in risk assessment methodologies including FMEA and statistical analysis techniques to identify, evaluate, and mitigate quality risks in visual inspection processes. Excellent communication and training skills to develop and deliver technical content to diverse audiences, ensuring consistent understanding and implementation of critical quality procedures across manufacturing teams.

Market Demand

High demand driven by Ireland's position as a global pharmaceutical manufacturing hub, regulatory compliance requirements, and the critical nature of visual inspection in ensuring product quality and patient safety.

Important Skills

Critical Skills

Regulatory compliance expertise is absolutely essential as visual inspection directly impacts product release decisions and patient safety, with regulatory violations potentially resulting in product recalls, facility shutdowns, and significant financial penalties. Process validation experience is crucial for ensuring manufacturing processes meet regulatory requirements and quality standards, with validation failures potentially delaying product launches and impacting market competitiveness. Technical leadership capabilities are vital for managing complex projects involving multiple stakeholders, tight timelines, and high regulatory stakes that require decisive decision-making and clear communication.

Beneficial Skills

Statistical analysis and data trending capabilities enhance ability to identify process improvements and proactively address quality risks before they impact manufacturing operations. Digital technology familiarity including automation systems and data analytics tools positions candidates for future industry developments and process optimization initiatives. Cross-functional collaboration skills enable effective partnership with quality, manufacturing, and regulatory teams to achieve optimal outcomes in complex manufacturing environments.

Unique Aspects

Consultancy environment providing exposure to multiple pharmaceutical companies and diverse visual inspection challenges, accelerating professional development and industry knowledge acquisition.
Focus on validation and commissioning services offers specialized expertise development in high-demand technical areas that are critical for pharmaceutical manufacturing success.
Partnership with world's largest life science companies provides access to cutting-edge technologies and industry best practices that may not be available in single-company roles.
Project-based work structure enables involvement in strategic initiatives and facility startups that offer significant technical challenges and career advancement opportunities.

Career Growth

Progression to senior individual contributor roles typically occurs within 2-3 years, while advancement to management positions generally requires 3-5 years of demonstrated leadership success and expanded technical expertise.

Potential Next Roles

Senior Visual Inspection Engineer with expanded facility oversight Validation Manager leading site-wide compliance initiatives Quality Engineering Manager with broader quality system responsibilities Technical Operations Manager overseeing multiple manufacturing processes Regulatory Affairs Specialist focusing on CMC and manufacturing compliance

Company Overview

GerTEK Project Management and Technical Services

GerTEK Project Management and Technical Services operates as a specialized engineering consultancy focused on the life sciences sector, providing project management, talent solutions, and validation services to global pharmaceutical and biotechnology companies. The company has established itself as a trusted partner for complex technical projects requiring specialized expertise in highly regulated manufacturing environments.

Mid-tier consultancy with strong relationships among major pharmaceutical companies, competing in the growing market for specialized life sciences engineering services. The company's focus on validation and commissioning services positions it well in Ireland's expanding pharmaceutical manufacturing sector.
Strong presence in Ireland's pharmaceutical corridor with connections to major multinational companies operating in the region. The Sligo location provides access to both established pharmaceutical facilities and emerging biotechnology companies throughout the northwest region.
Project-focused environment with emphasis on technical excellence and client service delivery. The consultancy model typically offers exposure to diverse clients and projects, providing accelerated learning opportunities but requiring adaptability to different organizational cultures and working practices.
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