Manufacturing Expert Software (m|f|d)

Miltenyi Biotec

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profile Job Location:

Bergisch Gladbach - Germany

profile Monthly Salary: Not Disclosed
Posted on: 6 hours ago
Vacancies: 1 Vacancy

Department:

Manufacturing

Job Summary

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 GMPregulated manufacturing environment. This is a handson role requiring strong technical expertise in the design configuration testing validation and maintenance of MES workflows and electronic batch records combined with excellent problemsolving 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 this position you will play a key role in delivering highquality compliant manufacturing services to our clients.

  • 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 endtoend 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 crossfunctionally with Manufacturing QA QC IT and external partners to translate operational and regulatory requirements into effective MES solutions.
  • Provide handson MES support and expertise by delivering user training onsite 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 some years of 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.

Additional Information :

What we offer 

  • Diversity: International teams and cross-border intercultural communication  
  • Room for creativity: Its the most clever solution that we always strive for 
  • Health & Sport: We offer a wide range of corporate sports activities and health provision 
  • Miltenyi University: A clever mind never stops learning take advantage of our inhouse Training Academy 

Diversity is the bedrock of our creativity. 

Our mission: To innovate treatments and technologies and tackle the worlds most serious health challenges. And thats why we connect the dots across various disciplines linking different perspectives skills and abilities. 

You and your talent are welcome here in our inclusive and collaborative environment. So come as you are. Regardless of gender sexual identity age ethnicity religion or disability. 

Become part of our team and focus on pushing the borders of medicine. 

Contact us

If you have the skills and qualifications for this position please use the link to send us your details (application letter curriculum vitae references and certificates). Please give us some idea of when you can start and the kind of salary you are looking for.


Remote Work :

No


Employment Type :

Full-time

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 GMPregulated manufacturing environment. Thi...
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About Company

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For over 30 years, Miltenyi Biotec has been a major provider of products and services that drive biomedical research and boost cell and gene therapy. More than 4,700 employees in 23 countries combine excellence in research with innovative products to create cutting-edge solutions that ... View more

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