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Quality Assurance Validation Engineer - Job Opportunity at Sigmar

Sligo, Ireland
Contract
Mid-level
Posted: April 7, 2025
On-site
EUR 65,000 - 85,000 per year equivalent contract rate based on Irish biopharma market conditions

Benefits

Competitive contract rate
Experience with industry leader
Professional development opportunities in biopharma validation
12-month contract duration providing project completion exposure

Key Responsibilities

Lead validation programs for critical pharmaceutical equipment and processes
Develop and manage site-wide validation master plans
Ensure regulatory compliance with FDA and EU cGMP standards
Drive quality documentation and change control processes
Contribute to continuous improvement initiatives
Coordinate cross-functional validation activities

Requirements

Education

Bachelor's degree in engineering or scientific discipline

Experience

3+ years in biopharmaceutical industry

Required Skills

cGMP knowledge Validation expertise Regulatory compliance understanding Strong communication skills Independent work capability Team collaboration
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Sauge AI Market Intelligence

Industry Trends

Increasing focus on automation and digitalization in pharmaceutical validation processes requiring enhanced software validation skills Growing emphasis on data integrity and electronic systems validation in response to regulatory scrutiny Rising demand for validation engineers with combined equipment and computer system validation expertise Trend toward risk-based validation approaches requiring strategic thinking

Role Significance

Typically part of a 5-8 person validation team within larger quality organization of 20-30 professionals
Mid-level position with significant autonomous responsibility and potential for technical leadership

Key Projects

Equipment and utility validation programs Process validation initiatives Computer system validation projects Regulatory compliance documentation Validation master plan development

Success Factors

Strong technical foundation in validation principles and regulatory requirements Ability to manage multiple validation projects simultaneously Excellent documentation and technical writing skills Strong interpersonal skills for cross-functional collaboration Strategic thinking for risk-based validation approaches

Market Demand

High demand with significant growth projected due to expanding biopharma sector in Ireland and increasing regulatory requirements

Important Skills

Critical Skills

Validation expertise - Essential for ensuring product quality and regulatory compliance GMP knowledge - Fundamental to pharmaceutical operations Technical documentation - Critical for regulatory compliance Project management - Key for coordinating validation activities

Beneficial Skills

Risk assessment methodologies Statistical analysis capabilities Computer system validation expertise Change management experience

Unique Aspects

Opportunity to work in specialized therapeutic areas
Exposure to both EU and FDA regulatory frameworks
Combination of equipment and software validation responsibilities
Strategic location in Ireland's growing biopharma sector

Career Growth

2-3 years in role typically required before advancement to senior positions

Potential Next Roles

Senior Validation Engineer Validation Manager Quality Systems Manager Regulatory Compliance Manager

Company Overview

Sigmar

Global biopharmaceutical company focused on oncology and eye care, indicating strong market position in specialized therapeutic areas

Established player in the biopharmaceutical sector with significant investment in Irish operations
Part of Ireland's growing biopharma hub, with strategic importance in European operations
Professional environment with emphasis on quality and compliance, typical of regulated pharmaceutical operations
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  • Salary estimates and market demand analysis
  • Role significance and career growth potential
  • Critical success factors and key skills
  • Unique aspects of each position

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