Plant Engineer

Required Skills & Experience

Bachelor's degree in Mechanical Engineering, Chemical Engineering, Industrial Engineering, or related technical discipline.\n5+ years of engineering experience within pharmaceutical, biotechnology, biologics, or related GMP-regulated manufacturing environments.\nDirect experience supporting lyophilizers/lyophilization processes in a manufacturing or development setting.\nExperience managing or supporting capital projects involving process equipment installation and facility integration.\nWorking knowledge of commissioning, qualification, validation, and change control processes.\nExperience collaborating with cross-functional teams including MS&T, Manufacturing, Validation, Automation, Utilities, and Quality.\nStrong troubleshooting and root cause analysis skills.

Nice to Have Skills & Experience

Experience supporting biologics, vaccines, sterile manufacturing, gene therapy, or advanced therapy operations.\nExperience with cleanroom environments and GMP utility systems such as HVAC, WFI, clean steam, compressed air, and process gases.\nFamiliarity with equipment lifecycle management, reliability engineering, and preventive maintenance programs.\nPrevious experience supporting large-scale pharmaceutical capital projects exceeding $5M.

Job Description

Our client, a leading global biopharmaceutical manufacturer, is seeking a Plant Engineer to support a high-visibility capital project portfolio within its Manufacturing Sciences & Technology (MS&T) Development organization. This individual will play a key role in the planning, installation, startup, commissioning, and integration of new process equipment as part of a $6M-$15M equipment modernization initiative.\n\nThe ideal candidate will have experience supporting pharmaceutical manufacturing facilities, capital equipment projects, and utility systems, with direct experience working with lyophilization equipment (lyophilizers/freeze dryers). This role will partner closely with Engineering, MS&T, Manufacturing, Utilities, Validation, Automation, and Quality teams to ensure successful project execution while maintaining compliance with cGMP requirements.\n\nKey Responsibilities\nLead and support capital equipment projects from design through startup, commissioning, qualification, and operational handoff.\nServe as the engineering lead for installation and facility integration of new process equipment, including lyophilization systems.\nCoordinate with Utilities, Facilities, Manufacturing, Automation, Validation, and Quality teams throughout project execution.\nEvaluate facility and utility impacts associated with new equipment installations, modifications, and process improvements.\nSupport equipment FATs, SATs, commissioning, qualification activities, and operational readiness efforts.\nTroubleshoot equipment and utility-related issues and implement sustainable engineering solutions.\nDrive continuous improvement initiatives focused on reliability, maintainability, operational efficiency, and regulatory compliance.\nAuthor and review engineering documentation, change controls, SOPs, technical assessments, and project deliverables.\nEnsure all project activities comply with cGMP, safety, quality, and engineering standards.