Senior Process Engineer (Downstream)
Description Job Title: Senior Process Engineer (Downstream)Location: Woodlands, SingaporeAbout the role:Lead troubleshooting of manufacturing operations (Downstream) process/product issuesTechnical subject matter expert for manufacturing operations to resolve process issues, perform root cause analysis and impact assessment for process investigation Lead evaluation of new technologies, plan and execute process improvementsPlan and execute global manufacturing sciences initiativesLead, plan and execute site manufacturing sciences activities such as continuous process verification (CPV) program, technology transfer of new products and process monitoring and trendingHow you will contribute:Support site manufacturing (downstream) activities throughPlanning 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 issuesLeading complex process investigations to identify root cause and implement action plans to correct or prevent re-occurrencePlanning and executing process improvements and robustness projectsLeading cycle development for process parameters where applicableDrafting process training slides and providing process training to cross functional teamsRaising change controls as change owner for process changesPerforming impact assessments for relevant change controlsProviding technical /process parameters for creation and revision of master batch records. Review master batch records.Lead/Support technology transfer for new technologies/product introduction throughLeading the evaluation of new manufacturing technologies and/or equipment for process improvement or process capabilities buildPlanning and executing technical transfer activities according to project timelines. Raise change controls where applicable to support the technical transferMonitoring 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 documentsStrategizing and authoring process validation protocols and reports where neededAuthoring process related sections for regulatory submissionsMentor and train junior Manufacturing Sciences engineersAct as technical SME providing relevant technical inputs for process improvements, issues or process technical transferSupport audits, author regulatory submissions and responsesLead and execute global manufacturing sciences initiatives according to project timelinesResponsibility 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 RequirementsBachelor’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 areaHands-on experience with cell culture/ upstream processes and/or downstream processes in a manufacturing or development environmentHas knowledge of cGMPsKey Skills and CompetenciesStrong technical knowledge and expertise in process understanding and application in biopharmaceutical processes with ability to coach junior Manufacturing Sciences engineersStrong 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 skillsWillingness to learnTeam worker/ able to work in matrix environmentIndependent worker/ Self starterMore about us:At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work.Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.Empowering our people to shine:LocationsSGP - Singapore - WoodlandsWorker TypeEmployeeWorker Sub-TypeRegularTime TypeFull time