Process Engineer
Core
Lead local medical team and ensure alignment of local/regional medical strategy while providing technical support to manufacturing operations. (via careerplan.io/jobs/R5674466-process-engineer-at-viatris)
Role type
Process Engineer (Pharmaceutical Manufacturing)
Builds
Manufacturing operations, production targets, quality standards, and business objectives
Domain
Healthcare / Pharmaceutical Manufacturing
Required skills
GMP manufacturing operations, process engineering principles, equipment design, manufacturing systems, engineering project management, equipment qualification, process validation, technical documentation, root cause analysis, data analysis, Lean Manufacturing, Six Sigma, operational excellence
Preferred skills
New Product Introduction (NPI), technology transfer, process scale-up, commissioning, qualification, and validation (CQV), cleanroom operations, HVAC systems, purified water systems, clean steam, Steam utilization, Autoclaves, WFI still, Clean steam, HVAC systems, Compressed air, Filling lines, Packaging lines, PLC
Technologies
GMP, EHS, Quality, regulatory requirements, Lean, Six Sigma, problem-solving, operational excellence methodologies, data analysis, engineering tools
Responsibilities
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.
Seniority
Mid-level, hands-on IC
