Manufacturing Engineer Deviation - CDD 3 ans

Job content

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Job Description

About the role

This is an exciting career opportunity for a dynamic, autonomous, continuous improvement minded and change agile manufacturing professional to embrace a team-based culture and more specifically within the manufacturing teams within a world-class Biotech manufacturing environment.

How You Will Contribute

Within the Manufacturing Department, reporting to the Manufacturing Support Group, the purpose of this role is primarily to provide the technical expertise needed to investigate deviations within the manufacturing process and to act as a catalyst for continuous improvement. Main responsibilities of the Manufacturing Support Group are problem solving, creation of added value, standardization and improvement of manufacturing processes

Essential Duties & Responsibilities

As a deviation owner for the Manufacturing Department

• Initiate and manage deviations within the framework of production events and within quality systems (i.e. Trackwise) 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 moderate and high complexity/severity using root cause analysis tools (e.g. DMAIC, Is/Is Not, Cause & Effect Diagram, 5M, Contradiction Matrix, etc.), including management of investigation team and lead of workshop as appropriate
• Determine corrective and preventive actions (CAPA)
• Write complete investigation report and impact assessment
• Report out of findings/issues to high Management
• Participate in day-to-day operational support decisions, as needed
• Act as a Subject Matter Expert (SME) during internal and external audits for selected topics
• Participate to manufacturing process improvement and/or enhancement projects
• Incorporates and respects cGMP concepts (Good Manufacturing Practices)
  

Required Skills

What you bring to Takeda

• Strong knowledge and interest in detailed manufacturing operations (e.g. engineering designs, automated documentation) and biotechnological processes (USP and/or DSP).
• Ability to think and act cross-functionally, interacting with various SME (EHS, QA, QC, engineering, projects, etc.).
• Autonomous, structured, rigorous and self-motivated
• Able to manage priorities in a fast and dynamic environment with a high emphasis on achieving results
• Demonstrate excellent communication skills orally and written, ability to describe complex technical processes and qualifications and to translate it into clear, precise reports
• Team player prepared to work in a team-based culture including with the manufacturing personnel on the production floor, ability to listen and adapt to the audience.
• Excellent oral and written skills in English and French, fluency is an asset
  

Education & Experience

• 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, aseptic filling and lyophilization is a plus
• 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
  

Working Environment

• While this is a day-time job, must be able to work on occasions in controlled environments (ISO 5, ISO 7 and ISO 8 environments; grade A, B and C) requiring special gowning. Will be required to follow gowning requirements and wear protective clothing over the head, face, hands, feet and body.
  

What Takeda Can Offer You

• Attractive salaries
• Full accident cover
• Participation in health insurance premiums
• Advantageous retirement plans
• Subsidized meal
• Financial participation in the sports practices of its employees
• Transportation support in local public transport, free parking, carpooling program
• Takeda Neuchâtel offers to its employees an attractive framework and working conditions. The well-being, safety, development and career development of its employees are at the heart of our vision and of our Human Resources, Health, Environment and Safety policies.
• Takeda Neuchâtel is an employer committed to its employees and future generations.
  

More about us

At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work.

Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.

Empowering our people to shine

Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status or any other characteristic protected by law.

Locations

CHE - Neuchatel

Worker Type

Employee

Worker Sub-Type

Fixed Term (Fixed Term)

Time Type

Full time