Computer System Specialist

Jacksonstone Recruitment Ltd; Arklow; On-site; EUR 70,000 - 90,000; Full time

Job summary

Jacksonstone Recruitment Ltd is recruiting an experienced CSV Specialist and Site Data Integrity Lead for an Arklow pharmaceutical site on a two-year fixed-term contract. The role focuses on CSV governance and data integrity, leading data integrity activities and ensuring validated GxP systems while collaborating with Quality, IT and business teams.

You will prepare validation plans, risk assessments, and oversee lifecycle documentation, providing training and support for change controls and

Qualifications

• Experience in computer system validation within a regulated environment.
• Strong data integrity knowledge and risk-based validation.
• Excellent technical writing and documentation skills.
• Knowledge of GxP requirements and validation lifecycles.

Responsibilities

• Act as site SME for CSV and Data Integrity.
• Maintain validated GxP systems.
• Lead data integrity risk assessments, policies and training.
• Prepare validation plans, protocols, reports and lifecycle docs.
• Support change controls, periodic reviews and audit readiness.
• Oversee validation for system implementations and digital projects.
• Collaborate with Quality, IT and business teams.

Skills

CSV

Data Integrity

GxP experience

Technical writing

Quality systems

Regulated environment

Education

IT/Engineering/Science/Quality degree

Tools

GAMP 5

ERP

MES

LIMS

Job description

Computer System Validation (CSV) Specialist & Site Data Integrity Lead

• Arklow, Co. Wicklow
• Two-year fixed-term contract

We are recruiting an experienced CSV Specialist and Site Data Integrity Lead to join a leading pharmaceutical manufacturing site in Arklow.

This is a key compliance-focused position, combining site leadership for Data Integrity with Computer System Validation governance and project support.

Key responsibilities will include:

• Acting as the site SME for Computer System Validation and Data Integrity
• Maintaining GxP systems in a validated and compliant state
• Leading data integrity risk assessments, policies, controls and training
• Preparing validation plans, protocols, reports and lifecycle documentation
• Supporting change controls, periodic reviews and audit readiness
• Providing validation oversight for system implementations, upgrades and digital transformation projects
• Working closely with Quality, IT and business teams

The ideal candidate will have:

• A relevant qualification in IT, Engineering, Science or Quality
• Strong CSV experience within a regulated environmentKnowledge of GxP requirements, validation lifecycles and risk-based validation
• Excellent technical writing and documentation skills
• Experience with GAMP 5, ERP, MES or LIMS systems would be an advantage

This is an excellent opportunity to take ownership of CSV and Data Integrity activities within a highly regulated pharmaceutical environment.