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, ItalyRole Type: Long-term engagementWorking 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 ResponsibilitiesOperational Leadership
Serve as the primary on‐site IT operations lead for the pharmaceutical siteCoordinate daily operational activities across infrastructure, systems, laboratories, and industrial IT environmentsAct as the escalation point for operational and service‐related issuesEnsure effective communication between IT, QA, Facilities, Engineering, Manufacturing, and R&D stakeholders
Change & Release Management
Oversee change management processes for GxP-regulated systemsParticipate in Change Advisory Board (CAB) activitiesEnsure all changes follow approved validation, testing, and documentation proceduresCoordinate implementation windows and operational readiness activities
Incident & Service Management
Manage operational incidents including P1/P2 critical eventsCoordinate troubleshooting, escalation, vendor engagement, and resolution activitiesEnsure adherence to SLA and operational response targetsProvide out-of-hours support coverage as required
Compliance & Quality
Maintain compliance with pharmaceutical and regulatory requirementsSupport audit readiness and regulatory inspectionsEnsure proper maintenance of GxP asset inventories and configuration recordsSupport validation lifecycle activities and documentation reviewsOperate within established Quality Management System (QMS) procedures
Asset & Infrastructure Oversight
Maintain oversight of IT‐managed laboratory and industrial equipmentEnsure asset lifecycle tracking, configuration management, and validation status reportingCoordinate patching and maintenance activities under strict approval and testing controlsSupport infrastructure continuity, operational resilience, and service stability
The role requires prior experience working within regulated pharmaceutical or life sciences environments, including familiarity with:
EU GMPFDA 21 CFR Part 11GAMP 5Quality Management Systems (QMS)Computer System Validation (CSV) conceptsRegulated change control and documentation standards
RequirementsThe ideal candidate will demonstrate:
Proven experience in pharmaceutical or GxP-regulated IT environmentsStrong background in site-level IT operations, infrastructure management, or service delivery leadershipExperience supporting regulatory audits and inspectionsStrong stakeholder engagement and communication skillsAbility to coordinate across technical, operational, and quality teamsExperience managing critical incidents and operational escalationsStrong understanding of operational governance and compliance processesFull‐time on‐site presence during business hours (5 days/week)Availability for P1/P2 incidents outside standard hoursReachable within 30 minutes for critical operational escalationsParticipation in planned maintenance, audits, and major operational activities outside standard hours, where requiredSupport critical incident coverageEnsure uninterrupted service availability
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