ResponsibilitiesProvide Technical Leadership within the Drug Product manufacturing team including areas such as Formulation, Filling, Lyophilisation, Capping and Automated Visual Inspection.Execution of equipment qualification deliverables during execution of project phase including equipment Commissioning & Qualification, IOQ.Coordinate technical deliverables within Drug Product to support the successful product launch.Provide technical support to the operations team's during commercial manufacturing.Lead/participate in manufacturing investigations with cross-functional teams to ensure that detailed root cause analysis is completed and appropriate CAPAs are implemented.Support Batch Disposition activities by providing SME technical support for comment resolution.Identify and implement projects to continuously improve the compliance and manufacturing capabilities within the Drug ProductSupport continuous process and quality improvements through the deployment of Lean Six Sigma tools.Creation and revision of technical documents including manufacturing batch records, SOPs, and technical memos.In partnership with the site MS&T scientist the Principal Technical Support Specialist will provide comprehensive technical leadership to the DP organization.Participate in Regulatory, Client and Internal audits inspections as the technical representative.Delegate for Manufacturing Technical Lead.RequirementsBachelor of Engineering or Science Degree in Engineering or Technology related discipline.Minimum 5 years working in biological, vaccine or pharma facility. Preferred candidate will have cGMP with biological, vaccine or pharma facility with prior sterile manufacturing experienceAbility to operate within a matrix team to execute on the floor activities such as FAT, SAT, IQ/OQ and Engineering batchesExperience in data driven approach to root cause analysis and prioritization of continuous improvement initiatives e.g., Six SigmaExperience in leading & resolving complex technical investigationsExperience in a risk-based approach to manufacturing through use of tools such as FMEAAbility to adapt to changing priorities as project demands changePrevious experience in an operations role within vaccine manufacturing preferred.Knowledge of USP1790 and industry/ regulatory requirements such as Annex 1 desirableAbility to explain complex technical issues to external customers / agenciesExperience with lyophilized products advantageousExperience in start-up facility advantageousDemonstrated excellence in planning and organizational skills.Demonstrated skills in communication (oral and written) & in particular technical writing.Desired Skills and ExperienceBachelor's degree in Engineering or a Science-related field.Minimum of 5 years' experience in a biological, vaccine, or pharma facility, with strong preference for sterile manufacturing background.Proven experience in equipment qualification (C&Q, IOQ), technical investigations, root cause analysis, and CAPA.Skilled in applying Lean Six Sigma and risk-based tools (e.g., FMEA).Excellent technical writing and communication skills are essential.