We are seeking an experienced IT Operations Engineer to oversee IT infrastructure and operational activities within a GxP-regulated pharmaceutical environment. This is a hands-on, high-visibility role requiring strong operational leadership, stakeholder management, and compliance experience within regulated pharma environments.
Location: L’Aquila, Italy
Role Type: Long-term engagement
Working schedule: 5 days/week during standard business hours (Out-of-hours availability required for urgent P1/P2 incidents)
Language Requirements: Fluent Italian and English (written and spoken)
Key Responsibilities:
Operational Leadership
* Serve as the primary on-site IT operations lead for the pharmaceutical site
* Coordinate daily operational activities across infrastructure, systems, laboratories, and industrial IT environments
* Act as the escalation point for operational and service-related issues
* Ensure effective communication between IT, QA, Facilities, Engineering, Manufacturing, and R&D stakeholders
Change & Release Management
* Oversee change management processes for GxP-regulated systems
* Participate in Change Advisory Board (CAB) activities
* Ensure all changes follow approved validation, testing, and documentation procedures
* Coordinate implementation windows and operational readiness activities
Incident & Service Management
* Manage operational incidents including P1/P2 critical events
* Coordinate troubleshooting, escalation, vendor engagement, and resolution activities
* Ensure adherence to SLA and operational response targets
* Provide out-of-hours support coverage as required
Compliance & Quality
* Maintain compliance with pharmaceutical and regulatory requirements
* Support audit readiness and regulatory inspections
* Ensure proper maintenance of GxP asset inventories and configuration records
* Support validation lifecycle activities and documentation reviews
* Operate within established Quality Management System (QMS) procedures
Asset & Infrastructure Oversight
* Maintain oversight of IT-managed laboratory and industrial equipment
* Ensure asset lifecycle tracking, configuration management, and validation status reporting
* Coordinate patching and maintenance activities under strict approval and testing controls
* Support infrastructure continuity, operational resilience, and service stability
The role requires prior experience working within regulated pharmaceutical or life sciences environments, including familiarity with:
* EU GMP
* FDA 21 CFR Part 11
* GAMP 5
* Quality Management Systems (QMS)
* Computer System Validation (CSV) concepts
* Regulated change control and documentation standards
Requirements:
The ideal candidate will demonstrate:
* Proven experience in pharmaceutical or GxP-regulated IT environments
* Strong background in site-level IT operations, infrastructure management, or service delivery leadership
* Experience supporting regulatory audits and inspections
* Strong stakeholder engagement and communication skills
* Ability to coordinate across technical, operational, and quality teams
* Experience managing critical incidents and operational escalations
* Strong understanding of operational governance and compliance processes
* Full-time on-site presence during business hours (5 days/week)
* Availability for P1/P2 incidents outside standard hours
* Reachable within 30 minutes for critical operational escalations
* Participation in planned maintenance, audits, and major operational activities outside standard hours, where required
* Support critical incident coverage
* Ensure uninterrupted service availability