Senior Process Engineer
About The Position
The Senior Process Engineer supports aseptic filling operations and cross-functional improvement activities in partnership with Manufacturing, Quality, Validation, Reliability Engineering, and Supply Chain. Reporting to the Sr. Manager, Process Engineering Filling Lead, 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 position also provides significant technical input for capital projects that affect filling operations. The engineer leads technical projects and improvements that support filling quality, efficiency, and yield; manages technical aspects of change requests, non-conformances, and CAPA; troubleshoots equipment and component issues; and supports equipment introductions, specifications, protocols, and validation. The role provides technical support and training to Manufacturing and Maintenance, contributes expertise on the effects of filling operations on biologics, liaises with Regulatory on projects requiring submissions, and supports site inspections as a subject-matter expert. The position is based in an indoor office and manufacturing environment. It involves a combination of sedentary work, standing, and walking throughout the facility, with possible exposure to moving machinery, controlled environments, gowning requirements, and confined spaces. The role supports a 24/7 manufacturing operation and may require off-shift work, weekends, holidays, and overtime. Minimal travel is required.
Requirements
- Bachelor’s or advanced degree in science, engineering, or another related technical field.
- At least 3 years of related experience.
- Strong interpersonal skills and ability to work effectively and efficiently in a team-based environment.
- Experience leading projects, coordinating contractors, and directing technicians’ activities.
- Ability to organize and present technical and project-management overviews.
- Strong verbal and written communication skills, including creating and presenting 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.
- Ability to work non-traditional hours, including weekends and holidays, as needed; support off-shift hours and multiple shifts; and work overtime as required.
- Ability to carry and lift up to 25 pounds and push or pull up to 25 pounds, using material-handling equipment when needed.
- Ability to stand and/or walk for extended periods during an 8–12-hour shift and move between rooms and across the site.
- Ability to work around moving equipment and machinery, in controlled environments with gowning requirements, and potentially in confined spaces.
Nice To Haves
- 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 SolidWorks.
Responsibilities
- Identify and implement projects that improve the quality or efficiency of custom and commercial filling operations.
- Act as a technical leader across Quality, Manufacturing, suppliers, and relationship-management activities.
- Lead 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 identification, scoping, prioritization, review, tracking, execution, and reporting.
- Develop and share technical knowledge related to filling operations and associated exceptions through 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.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
