Manufacturing Engineer - CDD

By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’s Privacy Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge.

Job Description

Takeda is an industry-leading, global pharmaceutical company with an unwavering dedication to putting patients at the center of everything we do. We live our values of Takeda-ism – Integrity, Fairness, Honesty, and Perseverance – and are united by our mission to strive towards Better Health and a Brighter Future for people worldwide through leading innovation in medicine.

Here, everyone matters, and you will be a vital contributor to our inspiring, bold mission. At Takeda, you will make an impact on people’s lives – including your own.

Within the Manufacturing department, reporting to Deviation Experts Supervisor, the primary mission for theManufacturing 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

Locations

Worker Type

Worker Sub-Type

Time Type