Responsibilities* Provide technical leadership within a new Vaccine Drug Product Manufacturing facility.* Ensure all equipment installed is safe, effective and in compliance with industry standards.* Ensure all company and site engineering policies and procedures are adhered to.* Provide technical and compliance review and/or authorship of testing protocols, reports and applicable manufacturing SOPs.* Generate and execute documentation for cGMP activities including risk assessments /reports.* Management of Equipment Vendors including execution of on-site maintenance visits, management of continuous improvement projects & spare parts criticality assessments.* Support/lead maintenance of the validated state of the equipment through execution of revalidation protocols as per Site VMP.* Lead and participate in cross-functional teams to troubleshoot and resolve technical issues, drive continuous improvement, and process optimization using tools such as DMAIC and FMEA.* Manage changes to equipment/process as per site change control procedures.* Support establishment of new Preventative Maintenance Program for equipment in Drug Product suite.* Lead/participate in equipment related manufacturing investigations with cross-functional teams to ensure that detailed root cause analysis & impact analysis is completed and appropriate CAPAs are implemented.* Identify process and equipment improvements and develop these into CI projects.* Support disposition of batches by addressing any potential technical / engineering related issues which may have occurred mid-batch.* Lead/participate in, TPM, CI & Gemba programs and daily / weekly tiered manufacturing meetings.* Provide technical expertise during regulatory inspections e.g. FDA, HPRA inspections to defend systems, change controls, investigations and qualification packages.* Support transition from project to sustaining manufacturing and ramp up of production volumes in future by improving equipment reliability through CI and TPM processes.Qualifications/Experience* Bachelor of Engineering or Science Degree in Engineering or Technology related discipline* Minimum 5 years cGMP industrial / engineering experience,* Experience in executing on the floor activities such as FAT, SAT, IQ/OQ* Experience in data driven approach to root cause analysis and prioritisation of continuous improvement initiatives e.g. Six Sigma* Experience in leading & resolving complex technical investigations.* Experience in a risk-based approach to manufacturing through use of tools such as FMEA* Ability to adapt to changing priorities as project demands change.OTHER SKILLS, ABILITIES & EXPERIENCE:* Specific experience with Autoclave, Parts Washers, and CIP/SIP equipment.* Knowledge of Formulation processes.* Experience in start-up facilities is advantageous.* CQV experience is advantageous.* Knowledge of industry/ regulatory requirements such as Annex 1 desirable.* Ability to explain complex technical issues to external customers / agencies.* Demonstrated excellence in planning and organisational skills.* Demonstrated skills in communication (oral and written) & in particular technical writing.