Business Systems Analyst | Breda

(Koerber PAS|X – Systech | SAP | SCADA | Serialization)
Location: Breda
Industry: Biopharmaceutical Packaging / GMP Environment

Role Purpose

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 ERP

• Rockwell SCADA

• Level 2 automation interfaces
  This 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 Responsibilities

System Ownership & Support

• Manage 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 Leadership

• Lead/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 Collaboration

• Attend 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 Skills

• Strong 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.

Qualifications

Education

• Degree in Computer Science, Information Systems, Engineering, Life Sciences, or relevant industry experience.

Experience – Minimum

• 6+ 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.

Languages

• Fluent in spoken & written English.

Other

• Willingness to participate in on-call / after-hours support.

Preferred Experience

Experience with:

• Koerber PAS|X

• Systech Serialization (Guardian / Advisor)

• Rockwell FactoryTalk SCADA

• Aveva PI Data Historian

• Oracle, SQL, Unix/Linux

• ITIL framework (ITIL V3)

• Working in global pharma/biotech environments

• Technical 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.