Descrizione dell'offerta
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