Aptar Italia S.P.A.

Select how often (in days) to receive an alert: Create Alert IS Professional, Regulated Data Acquisition Systems Position: IS Professional, Regulated Data Acquisition Systems Reports To: IS Quality Manager Primary Purpose Summary The regulated DAQ systems specialist is responsible for implementing the lifecycle management of regulated Data Acquisition (DAQ) systems in accordance with FDA 21 CFR Part 11, GxP, and internal standards. They oversee design, implementation, and maintenance activities of DAQ systems used in quality critical processes, ensuring validated status, audit readiness, and continuous improvement. In addition, they act as application leader for Data Security Management Systems (ex: Compliance Builder). Job Responsibilities: Own the lifecycle of regulated DAQ systems (design, architecture, security, compliance, cost management) and data security management systems. Provide technical expertise to reach compliance with FDA 21 CFR Part 11, GMP, and Aptar IS standards. Review and follow Validation Master Plans (VMP) for DAQ systems in collaboration with sites QA managers and IS Validation manager. Author and maintain design and system administration documentation in IS Quality Management System. Oversees change requests, incident tickets, and CAPA actions for regulated DAQ systems. Propose and implement improvements for DAQ system management. Support audits and periodic reviews (user accounts, audit trails, qualification documents). Define and maintain backup/restore plans and preventive maintenance for regulated DAQ systems. Provide training and maintain SOPs, SWIs and guidelines for IS administrators. Ensure harmonized configuration across Pharma sites to minimize exceptions. Essential skills Strong technical expertise in workstations, servers, networks maintenance and administration. Experience with DAQ systems, validation processes (IQ/OQ/PQ), and audit readiness. Knowledge of Data Integrity principles (ALCOA+), FDA 21 CFR Part 11, and GMP. Quality and Compliance oriented mindset. IS Security principles awareness. Familiarity with ITSM tools (ServiceNow), document control systems (ETQ), and compliance software. Excellent communication and cross functional collaboration skills (planning management and customer relationship management). Education Bachelor's degree in computer science / software engineering / or similar preferred English (equivalent of Cambridge B2-C1) Experience Proven experience in regulated environments managing validated systems. Hands on experience with workstation configuration and administration. Project management and vendor coordination experience

A leading global company in Cambridge is seeking an IS Professional specializing in Regulated Data Acquisition Systems. You will oversee the lifecycle of regulated DAQ systems, ensure compliance with FDA regulations, and provide technical expertise throughout implementation and maintenance. Candidates should have a Bachelor's in a relevant field and proven experience in regulated environments. Excellent communication, collaboration skills, and a quality-oriented mindset are essential for this role.