Manufacturing Associate

**About the role**:
As a Manufacturing Associate, you will report to the Deviation Manager. The primary mission for the Manufacturing Associate is to support the manufacturing operations to meet their goals in terms of quality and productivity. You will specifically provide technical expertise needed to investigate deviations related to the manufacturing process and acts as a catalyst for continuous improvement. Your main responsibilities are problem solving, creation of added value, standardization and improvement of manufacturing processes.

**How you will contribute**:

- Initiate and manage deviations within the framework of production events and within quality systems in a timely manner
- Support evaluations related to impact on concerned equipment/product/material with the support of relevant Subject Matter Experts (SME)
- Perform investigations of low and moderate complexity/severity using root cause analysis tools (e.g. DMAIC, Is/Is Not, Cause & Effect Diagram, 5M, Contradiction Matrix, etc.)
- 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 process relevant to sub-group (PUT)
- Proactive 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
- Support report out of findings/issues to management and other sites
- Act as SME during internal and external audits with support of Manager, leads or Manufacturing Engineers
- Identify opportunities and propose ideas for improvement, in and out of deviations scope (including technical and organizational solutions)
- Participate to manufacturing process continuous improvement initiatives

**What you bring to Takeda**:

- CFC or HES Diploma with 3-5 years of experience within a biotech/pharmaceutical manufacturing environment (Process Operations or Quality)
- Technical knowledge of the biotechnological processes (USP, DSP and/or FF)
- 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.)
- Ideally demonstrated experience of Quality/Compliance requirements within cGMP manufacturing environment
- Experience and/or knowledge in a cGMP environment - 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 is a plus
- Ability to think and act cross-functionally, interacting with various SME - Good communication skills orally and written
- Proficiency in French, good oral and written skills in English required
- Experience in computerized / automated / QMS systems (ex: Trackwise, ERP, Veeva Vault)
- Good command of MS Office suite (Word, Excel, PowerPoint, Visio)
- Lean/Six Sigma Certification(s) is a plus

**What Takeda can offer you**:
We want our employees to succeed in everything they do - at work, at home, and in the community. This is why we offer world-class benefits and access to resources that can support people.

Our sector and the needs of our patients are constantly changing, which is why we emphasize continuous training. We actively support and invest in the development of our employees through a 50/40/10 training model.

We offer a comprehensive benefits package, prioritizing wellbeing, career growth, and work-life balance:

- Generous Time Off: 28 days of paid.
- Health & Wellbeing: Sport/Fitness abonnement contribution, on site cafeteria, medical annual check-ups starting at age 50, financial support and preventive health care insurance
- support for preventive healthcare.
- Family Support: Paid leave for maternity, paternity, and adoption, along with dedicated spaces for nursing mothers.
- Career Development: Access to a Learning Catalog, language courses, and opportunities for internal and international mobility.
- Transportation & Eco-Benefits: Contributions for public transport, incentives for e-biking, and on-site charging stations for electric vehicles. Regular on site gardening and massages activities.

**Important Considerations**:
At Takeda, our patients rely on us to create quality products and we aim to create a safe environment for our team members. As a result, we must follow strict rules in our manufacturing facilities to ensure we are not endangering the quality of the product or putting anyone at the site in harm's way. In this role, you may:

- Work in a controlled environment requiring special gowning and wear protective clothing over the head, face, hands, feet and body. This may include