Process Engineer-925394 in Niedergebra

Process Engineer- Sequencing: Scaling / Stabilizing complex, automated production lines / GxP documentation / NC) management / Deviations / Change Control / Continuous Improvement / Technical Supplier Management / English / Deutsch Tasks & Responsibilities: Shopfloor Support & SME Role: Provide direct, hands‑on technical support for daily production operations. Act as a Subject Matter Expert (SME) to support production operators during the exciting ramp‑up phase of our newly established production line. Proactively drive Continuous Improvement initiatives to optimize yield and efficiency. Document & Change Management: Create and maintain robust process documentation, change records, and work instructions in line with GxP standards. Product Care & NC Management: Take ownership of product care activities within the Squad. This includes handling non‑conformity notifications, leading structured investigations and root‑cause analyses, and coordinating corrective actions in the manufacturing process. Data‑Driven Process Monitoring: Monitor production data and analyze production and process performance indicators to ensure process stability and high quality. Global Collaboration & Coordination: Coordinate and collaborate closely with internal and external partners, including exchange with subject matter experts in Santa Clara, USA. Note: This requires flexibility regarding working hours for occasional evening meetings due to time zones. Regulatory Compliance: Work strictly according to internal processes defined by our GxP‑regulated environment. Must Haves: You bring a University degree in Natural Sciences or Engineering (e.g., Biotechnology, Biology, Chemistry, Molecular Biology, Material Science, Mechanical/Electrical Engineering) and/or a completed apprenticeship with equivalent professional experience in a related field You bring proven professional experience (2-3 years) within a highly regulated environment, backed by a strong quality awareness (GxP mindset) You bring a solid foundation in non‑conformity (NC) management, deviations, change control, and technical documentation You bring direct experience troubleshooting manufacturing operations and partnering closely with operators during production ramp‑up You bring high motivation for teamwork, excellent communication skills, and the ability to work independently within and across multi‑disciplinary teams You bring enthusiasm for taking on responsibility and proactively collaborating with a highly engaged team of engineers, operators, QA, and logistics. You bring a genuine interest in learning manufacturing technologies and continuously improving diverse sequencing processes to support our in‑house production efficiently You bring fluent communication skills in English and a good working knowledge of German (B2+) Nice to Haves: Proven experience in Technical Supplier Management (TSM) or similar roles, with a strong focus on managing supplier relations, changes and driving general technical or process change initiatives. Experience in data‑driven process monitoring and the ability to analyze key production performance indicators. Practical knowledge in planning and executing experiments, ideally utilizing statistical tools like Design of Experiments (DoEs) in a lab or production environment. Strong coaching and communication skills to act as a Subject Matter Expert (SME), with a passion for supporting shopfloor operators during a production line ramp‑up.