eSystems Specialist

Westbourne; Cork; Vor Ort; EUR 55.000 - 85.000; Vollzeit

Zusammenfassung

Westbourne seeks an experienced eSystems Specialist to support the implementation, administration, maintenance and continuous improvement of electronic systems within a regulated environment. The role involves collaborating with Quality, IT, Engineering, Validation, Manufacturing and other functions to ensure compliance, effectiveness and alignment with business needs.

The successful candidate will help manage eQMS and other validated platforms, participate in CSV activities, and contribute to

Qualifikationen

• Experience with electronic systems in regulated environments (pharma, biotech, medical device).
• Understanding of GMP/GxP requirements and data integrity principles.
• Experience supporting system implementation, validation, upgrades or improvements.
• Strong documentation and stakeholder management skills.
• Ability to work with Quality, IT, Engineering, Manufacturing and business teams.
• Troubleshooting, analytical, and problem-solving capabilities.

Aufgaben

• Support implementation, configuration, administration and maintenance of electronic systems.
• Act as primary contact for users and stakeholders on system issues and improvements.
• Support systems such as eQMS, document management, LMS, laboratory, manufacturing or other validated platforms.
• Gather and document business and system requirements.
• Support system upgrades, testing and implementation activities.
• Participate in CSV and lifecycle documentation where required.
• Prepare and review user requirements, functional specs, test scripts, SOPs and validation docs.
• Support change controls, deviations, CAPAs, investigations and compliance activities.
• Ensure systems comply with GxP, data integrity and regulatory requirements.
• Manage user access, workflows and periodic system reviews.
• Troubleshoot issues with IT teams, vendors and stakeholders.
• Support user training and provide guidance on system functionality.
• Identify opportunities to improve system performance and business processes.
• Maintain accurate system documentation and audit trails for inspection.

Kenntnisse

Documentation

Stakeholder management

Troubleshooting

Analytical thinking

Problem solving

Tools

eQMS

Veeva

TrackWise

Documentum

SAP

LIMS

MES

LMS

Jobbeschreibung

Role Overview

We are looking for an experienced eSystems Specialist to support the implementation, administration, maintenance, and continuous improvement of electronic systems within a regulated environment.

The successful candidate will work closely with Quality, IT, Engineering, Validation, Manufacturing, and other business functions to ensure electronic systems remain compliant, effective, and aligned with business requirements.

Key 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 systems, learning management systems, laboratory systems, manufacturing systems, 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 where required.
• Prepare and review documentation including user requirements, functional specifications, 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 applicable GxP, GMP, data integrity, and regulatory requirements.
• Manage user access, permissions, system workflows, and periodic system reviews where applicable.
• Troubleshoot system issues and coordinate with IT teams, vendors, and business 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 appropriate audit trails and records are available for inspection.

Required Experience

• Previous experience working with electronic systems / eSystems within a pharmaceutical, biotech, medical device, or regulated environment.
• Experience with one or more electronic platforms such as eQMS, Veeva, TrackWise, Documentum, SAP, LIMS, MES, LMS, or similar systems.
• Good understanding of GMP/GxP requirements and data integrity principles.
• Experience supporting system implementation, validation, upgrades, or continuous improvement projects.
• Strong documentation and stakeholder management skills.
• Ability to work effectively with Quality, IT, Engineering, Manufacturing, and business teams.
• Strong troubleshooting, analytical, and problem-solving skills.

Desirable Experience

• Experience with Computer System Validation (CSV).
• Knowledge of 21 CFR Part 11 and EU Annex 11.
• Experience with system administration, access management, workflow configuration, or electronic records management.
• Previous experience supporting audits or regulatory inspections.
• Experience working with external software vendors.