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Within the Manufacturing department, reporting to Deviation Experts Supervisor, 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.
This position is a fixed term contract. (7 months)
You role :
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 ouf of deviations scope (including technical and organizational solutions)
Lead or participate to manufacturing process continuous improvement initiatives
Coaching
Coaching and training of new arrivals and colleagues
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
Critical / Key skills:
- Proficiency in a cGMP 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
Language & IT Skills:
- 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