IT Systems in Quality Control Laboratories

• Set up, configure, and operate laboratory IT systems
• Install and configure workstations and related systems
• Integrate systems into corporate domain and Active Directory structures
• Manage user accounts, roles, and access rights at OS and domain levels
• Implement security controls, antivirus protection, and backup policies

Laboratory & Production Application Oversight

• Ensure controlled user access and proper authorization
• Maintain stable and compliant daily system operations
• Monitor performance and system availability

IT/OT Integration in Manufacturing

• Manage IT/OT aspects of pharmaceutical manufacturing equipment
• Lead system installation, configuration, and commissioning activities
• Coordinate integration between IT and OT environments

Business Continuity & System Reliability

• Maintain and verify backup and restore procedures
• Conduct business continuity and system availability checks
• Ensure operational resilience of site systems

Documentation & Validation Activities

• Execute and document system installation, configuration, testing, and go-live processes
• Prepare and maintain technical documentation required for regulated environments
• Support GxP-related lifecycle activities including:
• Participation in IQ / OQ / PQ
• Execution of test cases and documentation of results

Coordination & Leadership

• Collaborate closely with:
• Quality, Engineering, and Manufacturing teams on-site
• Central IT teams providing remote support
• Manage multiple parallel workstreams under time pressure
• Maintain compliance discipline and documentation accuracy

• Experience in regulated manufacturing environments (pharmaceutical, biotech, chemical, or food industries preferred)
• Experience supporting laboratory and/or manufacturing applications
• Familiarity with IT and OT systems operating together in industrial sites
• Strong documentation, validation, and testing mindset
• Solid planning, prioritization, and structured working approach
• Ability to operate independently on-site with remote coordination
• High stress tolerance and ability to deliver under tight deadlines
• Strong communication and team collaboration skills
• Ability to read and write technical documentation in English
• Awareness of GxP, CSV, 21 CFR Part 11, and/or EU Annex 11 requirements
• Experience with industrial equipment-related IT/OT systems
• Familiarity with information security frameworks (e.g., ISO 27001)

Strong Technical Knowledge Required

• Windows operating systems
• Windows Server environments
• Active Directory and domain structures
• User authorization and access control models