IT Systems Specialist

IT Systems Specialist

Role Overview

We are seeking an IT Systems Specialist to support validated Manufacturing and Laboratory systems within a regulated pharmaceutical manufacturing environment. The role focuses on ensuring the reliable operation, maintenance, and continuous improvement of critical IT systems that support production and laboratory operations.

The successful candidate will work closely with cross-functional technical and operational teams to ensure system stability, compliance, and alignment with quality and IT standards.

Key Responsibilities

• Manage and support validated Manufacturing and Laboratory (LAB) systems across site operations
• Implement system updates, new releases, and operational standards in line with IT and quality strategies
• Participate in or lead projects involving new equipment, system upgrades, and replacements (e.g., serialization systems, lab equipment, SAP, AI platforms, M365, etc.)
• Ensure compliance with Data Integrity requirements across all GxP systems
• Support Manufacturing systems including HMIs, MES platforms, and database environments (SQL/Oracle)
• Collaborate with global IT teams to integrate local infrastructure and build system interfaces
• Configure and manage Development, Validation, and Production environments
• Manage incidents, problems, changes, and release activities for lab and production systems
• Coordinate with external vendors for system support and issue resolution
• Administer application security and system access controls
• Ensure compliance with Computer System Validation (CSV) standards and SDLC processes
• Support internal and external audits (e.g., regulatory inspections such as FDA, MHRA)
• Maintain system documentation and operational standards in line with compliance requirements

Required Skills & Experience

• Degree in Computer Science, Information Technology, or related field, or equivalent experience
• Experience working in regulated environments (pharmaceutical, healthcare, or manufacturing preferred)
• Strong technical knowledge of Windows client-server environments
• Experience with SQL/Oracle databases and system administration
• Understanding of backup, restore, and disaster recovery processes
• Experience supporting enterprise applications and infrastructure systems
• Familiarity with Manufacturing Execution Systems (MES), Laboratory systems (LIMS), or similar platforms (preferred)
• Knowledge of Computer System Validation (CSV) and SDLC processes
• Strong troubleshooting, incident management, and system support skills
• Experience working with cross-functional and global IT teams

Do you have:

• A degree in Computer Science, Information Technology, or equivalent relevant experience
• Experience working in a highly regulated industry (e.g., pharmaceutical, healthcare, manufacturing, or similar)
• Exposure to Manufacturing and/or Laboratory systems (preferred)
• Strong hands-on technical experience in IT operations and infrastructure support
• Experience working with business applications and enterprise IT environments
• Technical knowledge of backup and restore processes, system databases, and Windows client-server environments
• Basic to intermediate project management skills, including participation in IT or infrastructure projec

Are you:

• A strong team player with excellent communication and collaboration skills
• Highly self-motivated, adaptable, and resilient in dynamic environments
• Commercially aware, with an understanding of the operational and financial impact of technical decisions
• Familiar with Computer System Validation (CSV) and SDLC methodologies in regulated environments