Senior Process Engineer

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Job Description

About the role

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.

How you will contribute

• 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.

What you bring to Takeda

• 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.

Preferred:

• 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.

Core Competencies

• 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 and root-cause analysis to resolve equipment, component, quality, and yield issues.

• Collaboration: Partners effectively with Manufacturing, Quality, Validation, Reliability Engineering, Supply Chain, Regulatory, suppliers, and contractors.

• Communication: Translates complex technical information into clear specifications, protocols, reports, training, and senior-management presentations.

• Adaptability: Supports a 24/7 manufacturing environment and responds effectively to shifting operational priorities.

Work environment and physical requirements

• The position requires a combination of sedentary work, standing, and walking throughout the facility to observe conditions or perform work.

• Must be able to carry and lift up to 25 pounds and push/pull up to 25 pounds, with assistance from material-handling equipment when needed.

• During observations and inspections, must be able to stand and/or walk for extended periods during an 8-12 hour shift and move between rooms and across the site.

• Work is performed indoors in both general office and manufacturing environments with air conditioning and heating.

• May work around moving equipment and machinery during observations.

• May be required to work in controlled environments and follow gowning requirements, including wearing protective clothing over the head, face, hands, feet, and body. Manufacturing-area restrictions may include no makeup, jewelry, contact lenses, nail polish, or artificial fingernails.

• May be required to work in confined spaces or areas during observations and inspections.

Schedule and travel requirements

• Must be able to work non-traditional hours, including weekends and holidays, as needed.

• Requires flexibility to work off-shift hours and support different shifts as needed.

• Must be able to work overtime as required.

• Must be able to work multiple shifts, including weekends, to support a 24/7 manufacturing operation as needed.

• Minimal travel required.

More about us:

At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best-in-class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work.

Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.

Takeda Compensation and Benefits Summary

We understand compensation is an important factoras you consider the next step in your career. We are committed to equitablepay for all employees, and we strive to be more transparent with our pay practices.

For Location:

U.S. Base Salary Range:

The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job. The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location.

For information about our benefits, please click here.

EEO Statement

Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.

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Job Exempt