Lab IT CSV Engineer - GMP Data Integrity Validation Hybrid

Simotechnology; Cork; Hybrid; EUR 55,000 - 75,000; Full time

Benefits offered by this job

Educational support

Career progression

Competitive salary

Job summary

SimoTech is recruiting an engineer with 3+ years in Computer Systems Validation and Laboratory IT systems to support a state-of-the-art pharmaceutical facility in Cork. The role sits within the Computerised Instruments team, offering hybrid working arrangements and exposure to a GMP/GxP environment.

The ideal candidate will ensure data integrity, security, lifecycle management and regulatory compliance across multiple instrument systems in manufacturing operations.

Qualifications

• 3+ years’ experience validating laboratory computerized systems.
• Experience in GMP environment and data integrity.
• Knowledge of 21 CFR Part 11 and data integrity guidelines.
• Experience with IT applications change control.
• Strong interpersonal and communication skills across functions.

Responsibilities

• Manage the Lab System CSV deliverables from initiation to release, prioritising activity per project schedules.
• Generate validation documentation per site procedures and regulatory guidelines such as 21 CFR Part 11 and EU GMP Annex 11.
• Collaborate with 3rd parties to install computerized instrument solutions and integrate with on-site IT services.
• Initiate and implement Change Control activities in line with quality standards.
• Support EHS procedures and assist in incident investigations; participate in team meetings.

Skills

IT Applications

Validation

GxP compliance

Data integrity

Documentation

Regulatory knowledge

Cross-functional collaboration

Tools

MS Office

Software installation

Job description

SimoTech is recruiting an engineer with 3+ years in Computer Systems Validation and Laboratory IT systems to support a state-of-the-art pharmaceutical facility in Cork. The role sits within the Computerised Instruments team, offering hybrid working arrangements and exposure to a GMP/GxP environment.

The ideal candidate will ensure data integrity, security, lifecycle management and regulatory compliance across multiple instrument systems in manufacturing operations.