Takeda
ProcessEngineerII(Upstream)
Neural analysis suggests this role is
optimal for Mid candidates.
“Process Engineer II (Upstream) at Takeda. Skills: Process Engineer, Upstream process/product issues troubleshooting, Root cause analysis, Process improvements, Technology transfer, cGMPs. Support/lead troubleshooting of manufacturing operations Upstream process/product issues. Resolve process issues”
What You'll Achieve.
Ensure process robustness
Industry & Context.
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; Analyzing process trends; Monitoring process performance; 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; Proactively investigate where required to ensure process robustness; analytical skills including demonstration of systematic evaluation of potential issues, correlation or cause and effect relationships, root cause analysis methodology
Responsibility to adhere to any applicable EHS requirements
What They're Looking For.
Must Have
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, Knowledge of cGMPs
What You'll Do.
Support/lead troubleshooting of manufacturing operations Upstream process/product issues
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
support and execute site manufacturing science activities
Support site manufacturing upstream activities
Perform process impact assessment
Participate and perform root cause analysis
Analyze process trends
Monitor process performance
Investigate out of trend or process issues
Implement action plans to correct or prevent re-occurrence
Lead/support cycle development for process parameters
Draft process training slides and provide process training
Raise change controls as change owners
Perform impact assessments for relevant change controls
Provide technical /process parameters for creation and revision of master batch records
Review master batch records
Lead/Support technology transfer for new technologies/product introduction
Evaluate new manufacturing technologies and/or equipment
Execute technical transfer activities
Monitor process performance and trending
Perform risk assessment
Draft required technical transfer and process control strategy documents
Update lifecycle documents
Author study and process validation protocols and reports
regulatory submissions and responses
Support and execute global manufacturing sciences initiatives
Adhere to any applicable EHS requirements
How You'll Work.
Team & Collaboration
Work with cross functional teams for process issues investigation; Able to work in matrix environment
Communication Scope
Good communication skills
Process & Methodology
Plan and execute process improvements and robustness projects, Plan, support and execute site manufacturing science activities, Execute technical transfer activities according to project timelines
Full Job Description
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](https://jobs.takeda.com/privacynotice) and [Terms of Use](https://www.takeda.com/terms-and-conditions/). I further attest that all information I submit in my employment application is true to the best of my knowledge. ## **Job Description** **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 ch
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