Miltenyi Biotec

Manufacturing Expert Software (m|f|d)

Stellenbeschreibung:

Job Description

This position is part of the Manufacturing Team within the Cell Factory BGL organization. We are looking for a knowledgeable, proactive Manufacturing Execution System (MES) Specialist to support the implementation and continuous optimization of our MES in a GMP‑regulated manufacturing environment. The role requires strong technical expertise in designing, configuring, testing, validating, and maintaining MES workflows and electronic batch records, combined with excellent problem‑solving and communication skills.

The role involves close collaboration with internal and external stakeholders to build effective partnerships, ensuring compliance with cGMP requirements and Quality Management Systems. In this position, you will play a key role in delivering high‑quality, compliant manufacturing services to our clients.

Responsibilities

  • Drive MES excellence in a GMP environment by designing, configuring, testing, validating, and maintaining MES workflows and electronic Master Batch Records (MBR) to ensure compliant and efficient manufacturing execution.
  • Enable seamless system integration by connecting MES workflows with ERP systems and manufacturing equipment, supporting end‑to‑end digital production processes.
  • Ensure quality and compliance through the creation and maintenance of robust technical documentation, including SOPs, user manuals, and validation test cases, in line with cGMP and data integrity requirements.
  • Collaborate cross‑functionally with Manufacturing, QA, QC, IT, and external partners to translate operational and regulatory requirements into effective MES solutions.
  • Provide hands‑on MES support and expertise by delivering user training, on‑site technical support, and ongoing communication with internal stakeholders, reporting regularly to the MES System Owner.

Qualifications

  • Degree or equivalent background in Automation, Industrial IT, Engineering, Pharmaceutical Manufacturing, or a related technical field with relevant experience working with Manufacturing Execution Systems (MES) and associated software platforms.
  • Proven experience in pharmaceutical or other regulated manufacturing environments; solid understanding of Computerized System Validation (CSV) is an advantage.
  • Strong analytical mindset with a high level of accuracy and attention to detail in configuring, testing, documenting, and delivering MES solutions.
  • Ability to thrive in dynamic environments, with strong skills in task prioritization and project management.
  • Excellent verbal and written communication skills, including technical documentation; English is mandatory, German is a plus.

Benefits

  • Diversity: International teams and cross‑border intercultural communication.
  • Room for creativity: The organization encourages innovative solutions.
  • Health & Sport: A wide range of corporate sports activities and health provision.
  • Miltenyi University: In‑house Training Academy for continuous learning.

Equal Opportunity & Diversity

Diversity is the bedrock of our creativity. Our mission is to innovate treatments and technologies and tackle the world’s most serious health challenges. We welcome talent from all backgrounds and strive to create an inclusive and collaborative environment for everyone.

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Stelleninformationen

  • Veröffentlichungsdatum:

    18 Mai 2026
  • Standort:

    Bergisch Gladbach

    Einsatzort:

    Lüdinghausen, Germany
  • Typ:

    Vollzeit
  • Arbeitsmodell:

    Vor Ort
  • Kategorie:

  • Erfahrung:

    2+ years
  • Arbeitsverhältnis:

    Angestellt

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