Senior Process Engineer (Upstream)

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Job Description

About the role:

The Senior Process Engineer is to lead troubleshooting of manufacturing operations (Upstream/ Downstream) process/product issues. Technical subject matter expert for manufacturing operations to resolve process issues, perform root cause analysis and impact assessment for process investigations. Lead evaluation of new technologies, plan and execute process improvements. Plan and execute global manufacturing sciences initiatives. Lead, plan and execute site manufacturing sciences activities such as continuous process verification (CPV) program, technology transfer of new products and process monitoring and trending.

Responsibilities:

• Support site manufacturing (upstream/downstream) activities through

  • Planning and executing activities required for process investigation such as performing process impact assessment, participating and performing root cause analysis. Facilitate stakeholder buy-in from cross functional teams for action plans

  • Analyzing process trends, monitoring process performance as part of the CPV program. Escalate and lead investigation in event of any out of trend or process issues

  • Leading complex 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 cycle development for process parameters where applicable

  • Drafting process training slides and providing process training to cross functional teams

  • Raising change controls as change owner 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 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

  • Strategizing and authoring process validation protocols and reports where needed

  • Authoring process related sections for regulatory submissions

• Mentor and train junior Manufacturing Sciences engineers

• Act as technical SME providing relevant technical inputs for process improvements, issues or process technical transfer

• Support audits, author regulatory submissions and responses

• Lead 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 at least 6 years of relevant experience or Master’s Degree with 4 years of relevant work experience or a PhD with at least 2 years of work experience 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 expertise in process understanding and application in biopharmaceutical processes with ability to coach junior Manufacturing Sciences engineers

• Strong analytical skills including demonstration of systematic evaluation of potential issues, correlation or cause and effect relationships, root cause analysis methodology. Able to identify risk mitigation actions for implementation.

• Strong communication, stake holder management, project management and conflict resolutions skills

• Willingness to learn

• Team worker/ able to work in matrix environment

• Independent worker/ Self starter

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