Plant Engineer

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.

The 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.

Key Responsibilities Lead and support capital equipment projects from design through startup, commissioning, qualification, and operational handoff. Serve as the engineering lead for installation and facility integration of new process equipment, including lyophilization systems. Coordinate with Utilities, Facilities, Manufacturing, Automation, Validation, and Quality teams throughout project execution. Evaluate facility and utility impacts associated with new equipment installations, modifications, and process improvements. Support equipment FATs, SATs, commissioning, qualification activities, and operational readiness efforts. Troubleshoot equipment and utility-related issues and implement sustainable engineering solutions. Drive continuous improvement initiatives focused on reliability, maintainability, operational efficiency, and regulatory compliance. Author and review engineering documentation, change controls, SOPs, technical assessments, and project deliverables. Ensure all project activities comply with cGMP, safety, quality, and engineering standards.

Skills and Requirements

Bachelor's degree in Mechanical Engineering, Chemical Engineering, Industrial Engineering, or related technical discipline. 5+ years of engineering experience within pharmaceutical, biotechnology, biologics, or related GMP-regulated manufacturing environments. Direct experience supporting lyophilizers/lyophilization processes in a manufacturing or development setting. Experience managing or supporting capital projects involving process equipment installation and facility integration. Working knowledge of commissioning, qualification, validation, and change control processes. Experience collaborating with cross-functional teams including MS&T, Manufacturing, Validation, Automation, Utilities, and Quality. Strong troubleshooting and root cause analysis skills. Experience supporting biologics, vaccines, sterile manufacturing, gene therapy, or advanced therapy operations. Experience with cleanroom environments and GMP utility systems such as HVAC, WFI, clean steam, compressed air, and process gases. Familiarity with equipment lifecycle management, reliability engineering, and preventive maintenance programs. Previous experience supporting large-scale pharmaceutical capital projects exceeding $5M.

We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal employment opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment without regard to race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or the recruiting process, please send a request to [email protected].