Manufacturing Science Process Engineer
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Process Engineer – Formulation Fill Finishing
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.
The scope of this role is to act as Fill and Finish process engineer within the Manufacturing Sciences Department (MS) at the Neuchâtel facility ensuring process performances for a recombinant protein during formulation and lyophillization activities.
The jobholder will lead projects related to process improvement and technology transfer from or to other Shire facilities. The jobholder will support manufacturing and quality departments regarding impact assessment, investigation and troubleshooting.
- Lead process improvement projects or activities
- Develop and optimize process parameters
- Ensure process performances through Quality by Design (QbD) and Continuous Process Verification (CPV) approaches
- Identify business opportunities
- Ensure communication and act proactively in case of performance trending
- Lead and/or support investigations related to deviation/CAPA process
- Perform product impact assessment for deviation
- Lead projects or activities related to Fill and Finishing process or equipment (from User Requirements Specifications to Process Performance Qualification)
- Support validation activities
- Support or present topic during regulatory inspections
- Support technology transfer
Education / experience and abilities
- Minimum 3-5 years of experience in formulation and/or lyophilization area for recombinant protein.
- Engineering or university degree in biotechnology
- Language skills: Fluent in English and French
- Knowledge of cGMP and quality requirements
- Able to deal with statistics (six sigma certification is a plus)
Notice to Employment / Recruitment Agents:
Employment / Recruitment agents may only submit candidates for vacancies only if they have written authorization to do so from Shire, a wholly-owned subsidiary of Takeda’s Talent Acquisition department. Any agency candidate submission may only be submitted to positions opened to the agency through the specific Agency Portal. Shire, a wholly-owned subsidiary of Takeda will only pay a fee for candidates submitted or presented where there is a fully executed contract in place between the Employment / Recruitment agents and Shire, a wholly-owned subsidiary of Takeda and only if the candidate is submitted via the Agency Portal. Candidates submitted or presented by Employment / Recruitment Agents without a fully executed contract or submitted through this site shall not be deemed to form part of any Engagement for which the Agency may claim remuneration.
Job ID SR0050479