Matrix Recruitment are currently recruiting for a Process Engineer - Drug Product - Formulation on behalf of our client based in Louth. What you need to know: Fully onsite role, days only, no shift. Your New Job: The Process Engineer will develop and transfer knowledge of Lean Six Sigma, Change Management and Inclusion. Steer and/or participate in cross-functional investigations on problems/deviations-including defining corrective and preventive actions. Identify, analyze and prioritize technical or business-related processes improvement-opportunities and problems. Initiate and coordinate improvements for technical or business processes, systems and behaviours. Contribute to a data driven decision making process, ensure effective application of Lean Six Sigma and Change Management tools by leading projects, facilitating kaizens and coaching sponsors and practitioners. Minimal work direction needed, highly skilled and knowledgeable to the position. Key Duties and 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. What are we looking for? 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. Specific experience with Autoclave, Parts Washers, and CIP/SIP equipment. Knowledge of Formulation processes. CQV experience is advantageous. Apply for this job now or get in touch with Brenda on By applying, you are giving consent for Matrix Recruitment to contact you about this job. We collect your data for recruitment purposes only and will retain it for the duration required as outlined in our privacy policy. All CVs are kept confidential and will not be submitted to any clients without your knowledge and permission. Please note that due to the expected high volume of applications we can only reply to applicants suitable for the position. We Value Your Trust. Skills: Drug Product Formulation Autoclave