Manufacturing Quality Systems Expert m/f/w
We are seeking a Manufacturing Systems & Quality Specialist to ensure the design, deployment, maintenance, and continuous improvement of manufacturing systems. This role provides technical expertise, supports operations, and ensures compliance with GMP/GxP guidelines and local QA procedures. The position requires strong collaboration with cross-functional teams and a commitment to operational excellence.
Project title: Manufacturing Systems / Quality Expert m/f/w
Type of employment: Payroll
Skills: MES, Quality, PasX
Project start: 01.01.2026
Tasks:
* Design, deploy, maintain, and improve manufacturing systems.
* Deliver end-user training prior to system go-live and for future updates or changes.
* Provide frontline support to operations.
* Prepare and maintain system procedures and reports for large-scale manufacturing activities.
* Offer technical expertise for decision-making during manufacturing issues.
* Contribute to qualification and validation activities in collaboration with stakeholders.
* Ensure compliance of manufacturing systems with applicable guidelines, standards, and QA procedures.
* Initiate and support deviation investigations, CAPA definition and implementation, and CCPs.
* Drive operational excellence within the field of competence.
Qualifications:
* Degree in Life Sciences, Engineering, or related field (e.g., Biomedical Science, Chemistry, Pharmacy, Biotechnology).
* Solid understanding of GMP/GxP regulations and manufacturing processes.
* Hands-on experience in manufacturing systems (design, deployment, maintenance, improvement).
* Proven track record in QA processes: deviation management, CAPA, change control, CCPs.
* Experience with qualification/validation activities in a regulated environment.
* Frontline support to operations and ability to train end users.
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