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Manufacturing expert software (m|f|d)

Bergisch Gladbach
Miltenyi Biotec
Inserat online seit: Veröffentlicht vor 11 Std.
Beschreibung

Company Description

For more than years, we have been developing cutting-edge science and technology to empower biomedical research and personalized medicine. We combine excellence from more than disciplines in natural sciences, engineering, and informatics to make a significant contribution to biomedical sciences. We encourage a creative working environment driven by pioneering spirit – to seek new horizons – boldly envisioning the future and turning it into reality. Today, more than 5, experts from over countries contribute to our sustainable success.

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. This is a hands‑on role requiring strong technical expertise in the design, configuration, testing, validation, and maintenance of 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.

1. 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.
2. Enable seamless system integration by connecting MES workflows with ERP systems and manufacturing equipment, supporting end‑to‑end digital production processes.
3. 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.
4. Collaborate cross‑functionally with Manufacturing, QA, QC, IT, and external partners to translate operational and regulatory requirements into effective MES solutions.
5. 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

6. 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.
7. Proven experience in pharmaceutical or other regulated manufacturing environments; solid understanding of Computerized System Validation (CSV) is an advantage.
8. Strong analytical mindset with a high level of accuracy and attention to detail in configuring, testing, documenting, and delivering MES solutions.
9. Ability to thrive in dynamic environments, with strong skills in task prioritization and project management.
10. Excellent verbal and written communication skills, including technical documentation; English is mandatory, German is a plus.

Additional Information

What we offer

11. Diversity: International teams and cross-border intercultural communication
12. Room for creativity: It’s the most clever solution that we always strive for
13. Health & Sport: We offer a wide range of corporate sports activities and health provision
14. 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 world’s most serious health challenges. And that’s 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.

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