Regulated eSystems Specialist: CSV, GxP & Compliance

Westbourne IT Global Services; Limerick; On-site; EUR 65,000 - 90,000; Full time

Job summary

Westbourne IT Global Services is seeking an experienced eSystems Specialist to support implementation, administration, and continuous improvement of electronic systems in a regulated environment. You will collaborate with Quality, IT, Engineering, Validation, Manufacturing and other functions to ensure systems stay compliant and effective.

You will lead documentation efforts, manage CSV activities, and support changes, deviations, CAPAs, and inspections while ensuring data integrity and user

Qualifications

• Experience with electronic systems in regulated environments (pharma/biotech/medical devices).
• Experience with platforms such as eQMS, Veeva, TrackWise, Documentum, SAP, LIMS, MES, LMS.
• Strong GMP/GxP knowledge and data integrity principles.
• Experience supporting system implementation, validation, upgrades, or improvements.
• Strong documentation and stakeholder management skills.
• Ability to collaborate with Quality, IT, Engineering, Manufacturing and business teams.
• Strong troubleshooting, analytical and problem-solving skills.

Responsibilities

• Support the implementation, configuration, administration, and maintenance of electronic business and quality systems.
• Act as a key point of contact for users and stakeholders regarding system-related queries, issues, and improvements.
• Support electronic systems such as eQMS, document management, learning management, laboratory, manufacturing or other validated platforms.
• Gather and document business and system requirements.
• Support system upgrades, enhancements, testing, and implementation activities.
• Participate in Computer System Validation (CSV) and system lifecycle documentation.
• Prepare and review documentation including user requirements, functional specs, test scripts, SOPs, work instructions, and validation documentation.
• Support change controls, deviations, CAPAs, investigations, and system-related compliance activities.
• Ensure systems are maintained in accordance with GxP, GMP, data integrity, and regulatory requirements.
• Manage user access, permissions, system workflows, and periodic system reviews.
• Troubleshoot system issues and coordinate with IT teams, vendors, and stakeholders to resolve problems.
• Support user training and provide guidance on system functionality and processes.
• Identify opportunities to improve system performance, usability, and business processes.
• Maintain accurate system documentation and ensure audit trails and records are available for inspection.

Skills

Troubleshooting

Analytical thinking

Documentation

Stakeholder management

Regulatory knowledge

Tools

eQMS

Veeva

TrackWise

Documentum

SAP

LIMS

MES

LMS

Job description

Westbourne IT Global Services is seeking an experienced eSystems Specialist to support implementation, administration, and continuous improvement of electronic systems in a regulated environment. You will collaborate with Quality, IT, Engineering, Validation, Manufacturing and other functions to ensure systems stay compliant and effective.

You will lead documentation efforts, manage CSV activities, and support changes, deviations, CAPAs, and inspections while ensuring data integrity and user