Senior Process Engineer

This position reports to the Sr. Manager, Process Engineering Filling Lead and supports aseptic filling operations and cross-functional improvement activities in partnership with Manufacturing, Quality, Validation, Reliability Engineering, and Supply Chain. The role provides technical expertise in precision web handling and tension control, thermal sealing technology, volumetric dosing systems, filling technologies, process optimization, equipment troubleshooting, and complaint investigations. The Process Engineer also provides significant technical input for capital projects that impact filling operations.

• Identify and implement projects that improve the quality and/or efficiency of custom and commercial filling operations.
• Act as a technical leader across Quality, Manufacturing, suppliers, and relationship-management activities.
• Lead the technical aspects of change requests, non-conformances, CAPA, and operational improvement programs.
• Lead troubleshooting of component and equipment issues to resolve complaints and reduce system downtime.
• Introduce new filling equipment, components, and technologies.
• Author and execute user requirement specifications, technical protocols, and validation protocols.
• Support Manufacturing and Maintenance teams with troubleshooting and training.
• Lead yield-improvement initiatives related to solution loss, overfill, and defects.
• Provide leadership for capital projects, including project identification, scoping, prioritization, review, tracking, execution, and reporting.
• Develop and share technical knowledge related to filling operations and associated exceptions through well-defined technical projects and disciplined planning and execution.
• Develop expertise in the impact of filling operations on biologics.
• Act as a liaison with Regulatory for projects requiring regulatory submissions.
• Support site inspections as a technical subject-matter expert.
• Lead and drive yield-improvement projects in support of higher yields.

• Bachelor’s or advanced degree in science, engineering, or another related technical field.
• 3+ years of related experience.
• Strong interpersonal skills and the ability to work effectively and efficiently in a team-based environment.
• Experience leading projects, coordinating contractors, and directing the activities of technicians.
• Ability to organize and present technical and project-management overviews.
• Strong verbal and written communication skills, including the creation and presentation of project proposals to senior management.
• Technical aptitude to troubleshoot system downtime, identify root causes, and propose effective solutions.
• Ability to author user and technical specifications, electrical schematics, mechanical drawings, technical protocols, and reports.
• Proficient computer skills and experience with Microsoft Word, Excel, and PowerPoint.
• Highly organized and detail focused.

• Bachelor’s or advanced degree in Mechanical Engineering.
• Experience with aseptic filling or other pharmaceutical fill operations.
• Familiarity with biotechnology manufacturing operations, including aseptic filling and packaging, and supporting systems such as CIP, SIP, plant utilities, and clean utilities.
• Experience with vision inspection systems and serialization in the pharmaceutical industry.
• Experience with Microsoft Project, AutoCAD, and Solid Works.

• Technical Expertise: Applies engineering knowledge to filling technologies, process optimization, equipment troubleshooting, validation, and continuous improvement.
• Leadership: Leads technical projects, coordinates internal and external resources, and drives issues through resolution.
• Problem Solving: Uses structured troubleshooting…