Process Engineer

Process Engineer Viatris Inverin, Ireland The Role & What You Will Be Doing Every day, we rise to the challenge to make a difference, and here s how the Process Engineer role will make an impact: This position will lead the local medical team, ensure alignment and execution of local/regional medical strategy, collaborate with cross-functional teams and influence key healthcare stakeholders to drive meaningful impact for patients and the business. Provide day-to-day technical support to manufacturing operations to ensure production targets, quality standards, and business objectives are achieved safely and efficiently Analyse existing manufacturing processes, equipment, and systems, identifying opportunities for optimisation, capacity enhancement, reliability improvement, cost reduction, and compliance improvements. Lead and support capital and continuous improvement projects from concept through design, procurement, installation, commissioning, qualification, validation, and handover to operations. Work with engineering contractors, equipment vendors, and service providers to ensure projects are delivered safely, on schedule, within budget, and in compliance with site requirements. Support New Product Introduction (NPI), technology transfer, process scale-up, and commercialization activities, ensuring successful integration into routine manufacturing operations. Develop, optimise, and maintain process parameters and manufacturing controls to ensure product quality, process robustness, reproducibility, and regulatory compliance. Specify, select, design, procure, install, upgrade, modify, commission, qualify, and validate manufacturing equipment, utilities, and process systems. Lead and support equipment, process, cleaning, and utility qualification and validation activities, including protocol generation, execution, deviation management, and final reporting. Ensure all engineering and manufacturing activities comply with GMP, Environmental Health & Safety (EHS), Quality, and regulatory requirements. Perform root cause investigations and implement effective corrective and preventive actions (CAPA) to address process, equipment, and operational issues. Prepare and maintain technical documentation, including Standard Operating Procedures (SOPs), engineering specifications, validation protocols and reports, risk assessments, change controls, commissioning documentation, and technical evaluations. Collaborate with Operations, Quality, Validation, Maintenance, Supply Chain, and external partners to support site objectives and project delivery. Deliver technical training and coaching to manufacturing and engineering personnel to support operational excellence and knowledge transfer. Drive a culture of continuous improvement through the application of Lean, Six Sigma, problem-solving, and operational excellence methodologies. Monitor process performance through data analysis and trending, identifying opportunities to improve quality, efficiency, reliability, and overall equipment effectiveness (OEE). Support regulatory inspections, customer audits, and internal audits, ensuring engineering systems and documentation are inspection-ready at all times. Perform other duties as assigned. About Your Skills & Experience For this role, we re looking for a candidate who has an effective combination of the following qualifications, skills, and experiences: Bachelor's Degree in Chemical Engineering, Mechanical Engineering, Process Engineering, Pharmaceutical Engineering, Biotechnology, Industrial Engineering, or a related scientific/engineering discipline. Proven experience in a pharmaceutical, biopharmaceutical, medical device, or regulated manufacturing environment. Demonstrated experience supporting GMP manufacturing operations. Strong understanding of process engineering principles, equipment design, and manufacturing systems. Experience managing engineering projects from concept through implementation. Knowledge of equipment qualification and process validation requirements. Experience authoring and reviewing technical documentation, including SOPs, protocols, reports, change controls, and risk assessments. Strong problem-solving, root cause analysis, and troubleshooting skills. Excellent communication and stakeholder management skills, with the ability to work effectively across multidisciplinary teams. Proficiency in data analysis and the use of engineering tools to identify process improvement opportunities. Familiar with Steam utilization, Autoclaves, WFI still, Clean steam, HVAC systems, Compressed air, Filling lines, Packaging lines, PLC Direct involvement in New Product Introduction (NPI), technology transfer, and process scale-up projects. Experience with commissioning, qualification, and validation (CQV) activities. Knowledge of cleanroom operations, HVAC systems, purified water systems, clean steam, and other GMP utilities. Experience applying Lean Manufacturing, Six Sigma, Operational Excellence, or Continuous Improvement methodologies. Apply Now