Validation Engineer

Next Generation Recruitment; Carlow; On-site; EUR 55,000 - 75,000; Full time

Benefits offered by this job

Collaborative culture

Strategic impact

Job summary

Next Generation Recruitment seeks a Validation Engineer for a premier biotech facility in Carlow, Ireland. You will spearhead equipment, process, and system qualifications to uphold cGMP standards and drive lifecycle management.

The role involves IQ/OQ/PQ, method transfers, risk assessments, audits support, and cross-functional collaboration to ensure data integrity and Right First Time outcomes.

Qualifications

• Bachelor's degree or higher (Engineering, Chemistry, or Life Sciences).
• 2-3+ years in pharmaceutical validation with IQ/OQ/PQ and cGMP experience.
• Proficiency in validation software/tools and LIMS; knowledge of FDA/EMA regulations.

Responsibilities

• Plan, execute, and document validation activities for equipment, utilities, facilities, and processes (IQ/OQ/PQ).
• Lead analytical method transfers, validations, and verifications in line with cGMP and regulatory guidelines.
• Perform risk assessments (e.g., FMEA) and root cause analysis for deviations, change controls, and CAPAs.
• Author and review validation protocols, reports, SOPs, and technical documentation ensuring data integrity.
• Support audits/inspections as SME, maintaining site readiness and Right First Time KPIs.
• Drive continuous improvement in validation systems using tools like 5 Whys and Fishbone diagrams.
• Collaborate cross-functionally to integrate validation into manufacturing operations.

Skills

IQ/OQ/PQ

cGMP

Data integrity

LIMS

Education

Bachelor's degree or higher in Engineering, Chemistry or Life Sciences

Tools

LIMS

Validation software

Job description

Validation Engineer - Pharmaceutical Industry

Lead validation innovation at a premier biotech facility.

Join a dynamic team at our state-of-the-art site in Carlow, Ireland - a key manufacturing center producing critical pharmaceutical products during an exciting expansion phase. As a Validation Engineer, you'll spearhead equipment, process, and system qualifications to uphold the highest compliance standards. Reporting to the Validation Manager, apply your technical expertise to drive seamless method transfers, IQ/OQ/PQ, and lifecycle management in a high-impact role.

Key Benefits of the Role

• Collaborative culture: Partner with high-performing teams focused on safety, cGMP compliance, and cutting-edge engineering.
• Strategic impact: Enable reliable production of essential medicines through robust validation strategies.

Core Responsibilities

• Plan, execute, and document validation activities for equipment, utilities, facilities, and processes (IQ/OQ/PQ).
• Lead analytical method transfers, validations, and verifications in line with cGMP and regulatory guidelines.
• Perform risk assessments (e.g., FMEA) and root cause analysis for deviations, change controls, and CAPAs.
• Author and review validation protocols, reports, SOPs, and technical documentation ensuring data integrity.
• Support audits/inspections as SME, maintaining site readiness and Right First Time KPIs.
• Drive continuous improvement in validation systems using tools like 5 Whys and Fishbone diagrams.
• Collaborate cross-functionally to integrate validation into manufacturing operations.

Qualifications We Value

• Bachelor's degree or higher (ideally in Engineering, Chemistry, or Life Sciences).
• 2-3+ years in pharmaceutical validation, with hands-on IQ/OQ/PQ and cGMP experience.
• Proficiency in validation software/tools, LIMS, and regulations (FDA, EMA).
• Desired: Biologics/vaccines validation, method transfer, and clean utilities experience.

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