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 optimisation 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.