Business System Analyst

Provide technical leadership, system ownership and project execution for the Manufacturing Execution System (Koerber PAS|X) and its integration with:Product Serialization System (Systech)SAP ERPRockwell SCADALevel 2 automation interfacesThis role supports both Commercial & Clinical packaging/labelling operations — ensuring seamless system performance, compliance and continuous improvement.You will develop, maintain, optimise and operate services that are critical to site operations.Key ResponsibilitiesSystem Ownership & SupportManage MES and Packaging Execution Platforms: handle service requests, incidents & change requests.Own lifecycle management of assigned IS automation systems.Analyse, design and implement solutions for new requirements and site expansion.Ensure system compliance with GxP, SOX, Data Privacy, Part 11 and Amgen global standards.Maintain system configuration & documentation (SOPs, specifications, administration procedures).Be the primary point of contact for application & infrastructure queries.Project Execution & Technical LeadershipLead/support initiatives to enhance packaging operations and system performance.Translate business requirements into technical solutions.Develop documentation and project artifacts according to project needs.Provide guidance, coaching & knowledge sharing to other team members.Participate in regulatory and internal audits; respond to findings and questions.Client & Cross-Functional CollaborationAttend and facilitate cross-functional meetings to optimize business processes.Understand and support local Amgen business processes and applications.Promote effective communication between business, IS teams and suppliers.Evaluate applications and recommend improvements based on data and trends.Required Knowledge & Problem-Solving SkillsStrong understanding of business processes in a GMP packaging environment.Applies analytical thinking across qualitative & quantitative data, trends and risk assessments.Anticipates and prevents potential issues proactively.Independently manages multiple assignments with minimal supervision.Develops practical and scalable technical solutions aligned with operational objectives.QualificationsEducationDegree in Computer Science, Information Systems, Engineering, Life Sciences, or relevant industry experience.Experience – Minimum6+ years in application development, system admin or application support.Strong experience with MES & Packaging Execution Systems.Hands-on expertise in automation or equipment engineering within an IS context.Worked in cGMP-regulated manufacturing (preferably Packaging).Familiar with FDA cGxP, 21 CFR Part 11, software validation.Knowledge of interfaces (e.g., OPC), data conversion, networking & infrastructure.Experience with Product Serialization.Ability to translate business requirements into IS solutions.LanguagesFluent in spoken & written English.OtherWillingness to participate in on-call / after-hours support.Preferred ExperienceExperience with:Koerber PAS|XSystech Serialization (Guardian / Advisor)Rockwell FactoryTalk SCADAAveva PI Data HistorianOracle, SQL, Unix/LinuxITIL framework (ITIL V3)Working in global pharma/biotech environmentsTechnical support of operating packaging facilities (PLC/SCADA, DCS, OEM Automation)Interested? Send your CV to Daria at d.finikova@panda-int.com or call +31202044502 for more info.