MidFull TimeEN
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About the role:
The Process Engineer II is to Support/lead troubleshooting of manufacturing operations Upstream process/product issues. Technical subject matter expert (SME) for manufacturing operations to resolve process issues, perform root cause analysis and impact assessment for process investigations. Support evaluation of technologies, plan and execute process improvements. Support and execute global manufacturing science initiatives. Plan, support and execute site manufacturing science activities such as continuous process verification (CPV) program, technology transfer of new products and process monitoring and trending.
Responsibilities:
Support site manufacturing upstream activities through
Planning and executing activities required for process investigation such as performing process impact assessment, participating and performing root cause analysis. Work with cross functional teams for process issues investigation
Analyzing process trends, monitoring process performance as part of the CPV program. Escalate and perform investigation in event of any out of trend or process issues
Leading process investigations to identify root cause and implement action plans to correct or prevent re-occurrence
Planning and executing process improvements and robustness projects
Leading/supporting cycle development for process parameters where applicable
Drafting process training slides and providing process training to cross functional teams
Raising change controls as change owners for process changes
Performing impact assessments for relevant change controls
Providing technical /process parameters for creation and revision of master batch records. Review master batch records.
Lead/Support technology transfer for new technologies/product introduction through
Leading/Supporting the evaluation of new manufacturing technologies and/or equipment for process improvement or process capabilities build.
Planning and executing technical transfer activities according to project timelines. Raise change controls where applicable to support the technical transfer.
Monitoring process performance and trending through the site CPV program. Proactively investigate where required to ensure process robustness.
Performing risk assessment, drafting required technical transfer and process control strategy documents and updating lifecycle documents.
Authoring study and process validation protocols and reports where needed.
Support audits, regulatory submissions and responses.
Support and execute global manufacturing sciences initiatives according to project timelines.
Responsibility to adhere to any applicable EHS requirements.
Commitment to a fair and respectful relationship to others and behavior in accordance with Takeda’s Code of Conduct.
Any other duties as assigned by supervisor.
What you bring to Takeda:
Education and Experience Requirements
Bachelor’s Degree in Biochemistry, Chemistry, Chemical Engineering, Biotechnology, Biochemical Engineering with minimum 3 - 4 years of relevant experience or Master’s Degree with 2 years of relevant work experience or a fresh PhD in the relevant technical area.
Hands-on experience with cell culture/ upstream processes and/or downstream processes in a manufacturing or development environment.
Has knowledge of cGMPs.
Key Skills and Competencies
Strong technical knowledge and proficiency in process understanding and application in biopharmaceutical processes
Strong analytical skills including demonstration of systematic evaluation of potential issues, correlation or cause and effect relationships, root cause analysis methodology
Good communication skills
Willingness to learn
Team worker/ able to work in matrix environment
Independent worker/ Self starter.
