Manufacturing Engineer
Vor 2 Tagen
For our client, an international company based in Neuchatel, we are looking for a Manufacturing Engineer
General Information:
Workplace: Neuchatel
Contract : Temporary
Start date : 01.02.2025
End date: 31.07.2025
Workload: 100%
Please note French fluent is mandatory for this position
Tasks and responsibilities:
Within the Manufacturing department, reporting to the 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.
* Deviation management
- 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.)
- Lead multi-disciplinary investigation teams and associated workshops as appropriate
- Perform interview in the frame of deviation related to human factors
- Collect/compile data and write investigation summary reports
- Define robust corrective and preventive actions
- 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)
* Deviation report out
- Proactive and autonomous follow-up of deviations under responsibility (including identification of potential issues/bottlenecks) to ensure timeliness completion of each step
- Propose technical and organizational solutions
- Accurate reporting to relevant follow-up platforms
- Ensure report out of findings/issues to high Management and other sites
Act as SME during internal and external audits
* Continuous improvement
- Identify opportunities and propose ideas for improvement, in and out of deviations scope (including technical and organizational solutions)
- Lead or participate to manufacturing process continuous improvement initiatives
Your profile:
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
Written and oral proficiency in French and English
Experience in computerized / automated / QMS systems (ex: Trackwise, ERP, Veeva Vault)
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