Manufacturing Engineer
vor 2 Wochen
Manufacturing Engineer (M/F/D)
Within the Manufacturing department, reporting to Deviation Manager, the primary mission for the Manufacturing Engineer is to support the manufacturing operations to meet their goals in terms of quality and productivity. He/she specifically provides technical expertise needed to investigate deviations related to the manufacturing process and acts as a catalyst for continuous improvement. Main responsibilities are problem solving, creation of added value, standardization and improvement of manufacturing processes
Tasks:
- Initiate and manage deviations within the framework of production events and within quality systems in a timely manner
- Perform evaluations related to impact on concerned equipment/product/material with the support of relevant Subject Matter Experts (SME)
- Perform investigations of low, moderate and high complexity/severity using root cause analysis tools (e.g. DMAIC, Is/Is Not, Cause & Effect Diagram, 5M, Contradiction Matrix, etc.)
- Identify relevant criteria to monitor efficacy of CAPA and ensure follow-up until closure of the record
- Technical expertise on manufacturing processes relevant to sub-group (PUT)
- Proactive and autonomous follow-up of deviations under responsibility (including identification of potential issues/bottlenecks) to ensure timeliness completion of each step
Qualification:
- Bachelor/Master in Engineering and 3-5 years of experience within a biotech/pharmaceutical manufacturing environment (Process Operations or Quality)
- Technical knowledge of the biotechnological processes (USP and/or DSP)
- Ideally demonstrated experience in “deviation” management including use of Six Sigma tools (e.g. DMAIC, Is/Is Not, Cause & Effect Diagram, 5M, Contradiction Matrix, etc.)
- Experience of Quality/Compliance requirements within cGMP manufacturing environment
- Strong knowledge in detailed manufacturing operations (e.g. engineering designs, automated documentation) and biotechnological processes (USP, DSP and/or FF)
- Experience in “deviation” management including use of Six Sigma tools
- Ability to think and act cross-functionally, interacting with various SME
- Excellent communication skills orally and written
- Written and oral proficiency in French and English
- Experience in computerized / automated / QMS systems (ex: Trackwise, ERP, Veeva Vault)
- Master MS Office suite (Word, Excel, PowerPoint, Visio)
- MiniTab or other statistics software is a plus
Requirements:
Start: 03.02.2025
Duration: 6 months
Capacity: 5 days per week
Location: Neuchatel, Switzerland
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