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
#J-18808-Ljbffr