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 Process Engineer also provides technical input for capital projects affecting filling operations. The position leads technical projects and operational improvements, supports equipment and process troubleshooting, introduces new filling equipment and technologies, and develops technical knowledge related to filling operations and their impact on biologics. It supports a 24/7 manufacturing environment, including off-shift work, weekends, holidays, and overtime as needed. Minimal travel is required. The role is based in an indoor office and manufacturing environment. Work involves sedentary activity as well as standing and walking throughout the facility, potentially for extended periods during 8–12 hour shifts. The position may involve moving equipment, controlled environments and gowning requirements, and confined spaces or areas during observations and inspections.
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; work 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, with material-handling equipment assistance 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 and, when required, in controlled environments with gowning requirements or confined spaces and areas.
- Must follow manufacturing-area restrictions that may include no makeup, jewelry, contact lenses, nail polish, or artificial fingernails.
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 to 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.
Benefits
- Takeda offers benefits; details are referenced through a benefits link in the posting.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
