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CSV Lead - Job Opportunity at SimoTech

Dublin, Ireland
Full-time
Senior
Posted: May 26, 2025
On-site
EUR 85,000 - 115,000 annually based on senior-level CSV expertise in Dublin's pharmaceutical sector, with potential for higher compensation given the specialized nature of drug product facility validation and the candidate's subject matter expert positioning

Benefits

High degree of professional autonomy enabling career development and strategic decision-making authority
Comprehensive skill development opportunities through exposure to cutting-edge manufacturing automation technologies
Access to prestigious pharmaceutical industry clients offering valuable networking and experience
Multi-disciplinary technical environment fostering cross-functional expertise development
Competitive compensation package with career progression pathways in specialized validation field

Key Responsibilities

Serve as the authoritative subject matter expert for Computer System Validation (CSV) activities, driving strategic compliance decisions for biopharmaceutical manufacturing operations
Lead comprehensive CSV strategy development and implementation ensuring regulatory compliance across entire facility automation lifecycle
Design and execute validation protocols, risk assessments, and qualification documentation that directly impact product quality and patient safety
Oversee critical testing phases including Factory Acceptance Testing (FAT), Site Acceptance Testing (SAT), Installation Qualification (IQ), and Operational Qualification (OQ)
Manage cross-functional stakeholder relationships including system owners, design teams, and commissioning teams to ensure seamless project delivery
Drive change control processes and documentation standards that maintain regulatory compliance throughout all project phases
Execute operational handover strategies ensuring smooth transition from project implementation to production operations
Provide strategic facility start-up support that directly impacts manufacturing readiness and time-to-market

Requirements

Education

Bachelor's degree in Engineering, Computer Science, Life Sciences or similar

Experience

Minimum 7 years' experience working on validation with at least 7+ years' experience leading the full validation lifecycle of automation and digital systems

Required Skills

Experience working with Rockwell systems FT Batch, FT View, Control Logix & Plant Pax Experience working with Werum Pas-X Proven experience with drug production, especially fill-finish operations Proven leadership ability Excellent interpersonal and communication skills Robust project experience
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Sauge AI Market Intelligence

Industry Trends

The pharmaceutical manufacturing sector is experiencing unprecedented growth driven by biologics and personalized medicine, creating high demand for specialized CSV professionals who can navigate complex regulatory requirements. Manufacturing automation systems are becoming increasingly sophisticated, requiring validation experts who understand both traditional pharmaceutical processes and modern digital technologies. Regulatory agencies globally are intensifying focus on data integrity and computerized system compliance, particularly in drug product manufacturing facilities. This trend is driving significant investment in validation capabilities and creating premium opportunities for experienced CSV professionals. The shift toward continuous manufacturing and Industry 4.0 technologies in pharmaceutical production is creating new validation challenges, requiring professionals who can bridge traditional CSV approaches with emerging digital validation methodologies.

Role Significance

Typically manages and coordinates with 5-12 validation professionals, engineers, and quality assurance specialists across commissioning, qualification, and operations teams, while serving as the primary validation interface with client stakeholders
This is a senior-level position with significant strategic responsibility, positioning the individual as the primary validation authority for a critical biopharmaceutical facility project. The role involves high-level decision-making authority and direct client interaction, indicating substantial organizational trust and impact.

Key Projects

New pharmaceutical facility validation from ground-up including automation systems, manufacturing equipment, and digital infrastructure Drug product fill-finish line qualification covering sterile manufacturing processes and critical quality systems Regulatory compliance initiatives for FDA and EMA inspections involving computerized system validation documentation

Success Factors

Deep understanding of pharmaceutical manufacturing processes combined with advanced knowledge of modern automation platforms like Rockwell and Werum systems Exceptional project management capabilities with proven ability to coordinate complex validation activities across multiple stakeholder groups while maintaining strict regulatory compliance Strong regulatory knowledge encompassing FDA 21 CFR Part 11, EU Annex 11, and ICH guidelines for computerized system validation in pharmaceutical manufacturing Leadership skills enabling effective management of cross-functional teams and clear communication of complex validation strategies to both technical and business stakeholders

Market Demand

Very high demand driven by Dublin's position as a major European pharmaceutical manufacturing hub, with limited supply of senior CSV professionals experienced in modern automation systems and regulatory compliance

Important Skills

Critical Skills

Rockwell automation systems expertise is essential as these platforms dominate pharmaceutical manufacturing automation, requiring deep technical knowledge for effective validation strategy development Werum Pas-X experience is highly valuable given its widespread adoption in pharmaceutical manufacturing execution systems, making this expertise crucial for modern facility validation Comprehensive understanding of CSV lifecycle methodology is fundamental to success, as the role requires strategic oversight of complex validation programs from initial planning through operational handover

Beneficial Skills

Fill-finish operations knowledge provides significant competitive advantage in drug product manufacturing facilities, where sterile processing validation requires specialized expertise Advanced project management capabilities enable effective coordination of complex validation activities across multiple stakeholder groups and technical disciplines Strong regulatory knowledge covering FDA and EMA requirements ensures validation strategies meet current compliance expectations and inspection readiness

Unique Aspects

Direct client-facing subject matter expert role providing significant professional visibility and strategic influence on major pharmaceutical facility projects
Combination of strategic validation leadership with hands-on technical involvement in cutting-edge manufacturing automation systems
Opportunity to work on new facility implementation from inception through operational handover, providing comprehensive project lifecycle experience
Access to advanced pharmaceutical manufacturing technologies including modern fill-finish operations and integrated automation platforms

Career Growth

Progression to senior management roles typically occurs within 3-5 years given the specialized expertise and strategic nature of CSV leadership in pharmaceutical manufacturing

Potential Next Roles

Senior CSV Manager overseeing multiple facility validation programs across pharmaceutical organizations Director of Validation and Compliance responsible for enterprise-wide computerized system validation strategies Principal Consultant specializing in pharmaceutical validation with focus on emerging technologies and regulatory compliance

Company Overview

SimoTech

SimoTech operates as a specialized engineering services provider focused on life sciences manufacturing automation and IT systems implementation. The company positions itself as a strategic partner for pharmaceutical and biotechnology companies requiring sophisticated manufacturing systems and regulatory compliance expertise.

Established player in the Irish and European pharmaceutical services market with demonstrated capability in complex facility projects for major biopharmaceutical clients, indicating strong technical credibility and industry relationships
Strategic positioning in Dublin leverages Ireland's status as a major European pharmaceutical manufacturing hub, providing access to multinational pharmaceutical companies and significant capital investment projects
Professional services environment emphasizing technical excellence and collaborative teamwork, with strong focus on regulatory compliance and client partnership relationships typical of specialized pharmaceutical consulting firms
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