Senior Process Engineer

Description

• 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.

Qualifications

• 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.
  
  
• 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