Takeda

ProcessEngineerII(Upstream)

Singapore, Singapore FULL TIME Remote Friendly
Market Sentiment
HIGH DEMAND

Neural analysis suggests this role is
optimal for Mid candidates.

The Brief

“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.

Problems you'll solve

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

Eligibility Requirements

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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