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CQV Engineer (Thermal Mapping) - Job Opportunity at WuXi Biologics

Dundalk, Ireland
Full-time
Mid-level
Posted: January 20, 2025
On-site
EUR 55,000 - 75,000 per year based on Irish market rates for specialized validation engineers

Benefits

Comprehensive benefits package typical of global biopharma organizations
Career development in a rapidly growing multinational company
Exposure to cutting-edge biologics manufacturing technologies
International work environment with global project exposure

Key Responsibilities

Lead thermal mapping validation activities for upstream and downstream processing facilities
Review and approve qualification documentation including URS, Risk Assessments, DQ, FAT, SAT, IOQ, PQ
Coordinate temperature mapping and validation of critical equipment (fridges, freezers, autoclaves, incubators)
Manage sterilization and sanitization validation programs
Ensure GMP compliance and maintain validation documentation
Drive continuous improvement initiatives in thermal systems validation

Requirements

Education

A degree in a life-science / engineering related discipline is required

Experience

Minimum of 3 years' experience in thermal mapping

Required Skills

Good understanding of bio-pharmaceutical industry and GMP Excellent communication and interpersonal skills Problem solving and troubleshooting abilities Cross-functional collaboration Initiative and autonomy Strong ethics and regulatory compliance
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Sauge AI Market Intelligence

Industry Trends

Increasing focus on cold chain validation due to temperature-sensitive biologics growth Rising regulatory scrutiny on thermal mapping validation in GMP facilities Integration of digital monitoring systems in thermal validation processes Growing demand for specialized validation engineers in biologics manufacturing

Role Significance

Typically part of a 5-10 person validation team within larger engineering department
Mid-level technical specialist role with significant impact on product quality and regulatory compliance

Key Projects

Facility startup validation programs Equipment qualification projects Thermal mapping studies for GMP storage areas Validation documentation system improvements

Success Factors

Deep understanding of GMP requirements and regulatory expectations Strong project management capabilities Ability to work independently while maintaining cross-functional relationships Technical expertise in thermal validation methodologies

Market Demand

High demand driven by expansion of biologics manufacturing facilities globally and increasing regulatory requirements for thermal validation

Important Skills

Critical Skills

Thermal validation expertise - essential for GMP compliance and product quality GMP knowledge - fundamental for regulatory compliance Technical documentation skills - critical for validation activities

Beneficial Skills

Project management capabilities Statistical analysis skills Digital monitoring system experience

Unique Aspects

Role combines technical expertise with quality system management
Opportunity to work in rapidly expanding biologics sector
Exposure to diverse projects and latest industry technologies

Career Growth

2-3 years in role before advancement opportunity based on performance and business growth

Potential Next Roles

Validation Lead Senior Validation Engineer Quality Systems Manager Technical Services Manager

Company Overview

WuXi Biologics

WuXi Biologics is a leading global CDMO specializing in biologics development and manufacturing services

Top 3 global biologics CDMO with strong market growth and expanding international presence
Strategic European manufacturing hub in Ireland supporting global operations
Fast-paced, innovation-focused environment with emphasis on technical excellence and regulatory compliance
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