Drug Product Process Engineer
Category: Bio-Bio-Pharmaceutical
Amazing opportunity for an experienec Drug Product Process Engineer with Formulation experience to work in a Vaccine Manufacturing company in Dundalk.
Role
- • 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.
Essential Requirements
- REQUIREMENTS:
- • 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 prioritization 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.
Details
LocationDundalkLocation typeOn SiteJob typecontractSalary€€€
