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Senior Process Engineer

Job Location:

Madison, OH - USA

Monthly Salary: Not provided by the employer

Posted: 2 September 2026 (21 hours ago)

Application Deadline: 30 November 2026

Vacancies: 1 Vacancy

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Job Summary

Position Overview

FCDI is recruiting for a Senior Process Engineer to support continued growth and ongoing customer projects within the Process Development (PD) team located in Madison WI. As a Contract Development and Manufacturing Organization (CDMO) FCDIs PD team supports multiple customer programs by onboarding developing and transferring robust manufacturing processes for a diverse portfolio of iPSC-derived cell therapy products.

We are seeking an experienced self-motivated and detail-oriented process development engineer to serve as a technical authority within the PD team for late-stage clinical and commercial process development this hands-on laboratory role you will continue building best practices technical frameworks and fit-for-purpose approaches for process characterization scale-up studies process control strategy development and process lifecycle planning. You will collaborate closely with PD leadership and other cross-functional teams to ensure that processes and supporting strategies are scientifically sound robust phase-appropriate and aligned with client needs and regulatory expectations.

The successful candidate will be motivated by the opportunity to partner closely with CDMO clients to plan execute and deliver high-quality process development work that meets project commitments and advances life-changing iPSC-derived therapies toward patient administration safely efficiently and with the highest standards of quality. This is an onsite role located at our sites in the Madison WI area.

Company Overview

At FUJIFILM Cellular Dynamics were unlocking the power of human cells to change lives. Using revolutionary induced pluripotent stem cell (iPSC) technology we drive advancements in drug discovery disease modeling cell therapy research tools and cell therapy manufacturing. Our mission is deeply meaningful and were looking for bold innovators to join us.

At FUJIFILM Cellular Dynamics youll thrive in a collaborative and cutting-edge environment that encourages creativity and celebrates breakthroughs. If youre ready to do work that makes a real impact and propels healthcare forward this is your chance to be part of something extraordinary for science patients and yourself.

Our headquarters is in Madison Wisconsin a dynamic city celebrated for its lakes parks cultural richness biotech leadership and access to world-class academia.

Fujifilm is globally headquartered in Tokyo with over 70000 employees across four key business segments of healthcare electronics business innovation and imaging. We are guided and united by our Group Purpose of giving our world more smiles. Visit: Description

Essential Job Functions

Independently conceive plan and lead process development activitiesfor multiple internal and external programs applying advanced engineering and scientific judgment to develop robust scalable and commercially relevant processes.
Evaluate and implement technologies that improve process understanding robustness scalability automation closure and GMP readiness for cell manufacturing processes.
Provide technical leadership and subject-matter expertisefor late-stage clinical process development activities including process characterization scale-up and scale-down studies design space development process control strategy development and process lifecycle planning.
Apply expert knowledge of relevant regulatory quality and engineering requirements including applicable ICH FDA GMP and industry guidance to ensure process development activities are scientifically sound phase-appropriate and aligned with regulatory expectations.
Analyze and interpret complex process and experimental data troubleshoot technical challenges identify root causes and recommend improvements to processes equipment experimental approaches and development strategies.
Make technically sound and scientific risk-based decisions and recommendations based on complex or incomplete sets of data clearly communicating technical risk tradeoffs and recommendations to internal and external stakeholders.
Develop and maintain accurate complete and compliant technical documentation including development plans study protocols and reports process characterization documents risk assessments process descriptions control strategy summaries technical reports and other project-related records.
Communicate process development strategies technical findings and project statusto cross-functional teams clients and diverse internal and external audiences through technical presentations written reports and project summaries.
Collaborate with cross-functional teams and with clientsto ensure process development activities support project timelines product quality regulatory requirements technology transfer needs and commercial objectives.
Provide technical leadership training and mentorshipto junior and mid-level engineers and scientists; promote consistency in experimental design process evaluation data analysis troubleshooting and documentation; and lead small- to mid-sized process development projects as assigned.
Identify and develop innovative potentially patentable process improvements technologies or approachesin support of the organizations research development and commercial objectives.
Perform other duties as assigned.

Required Qualifications

PhD in a biosciences or bioengineering discipline or other closely related field plus at least two (2) years of related experience; or a Masters degree in a comparable field plus at least five (5) years of relevant experience; or a Bachelors degree in a comparable field plus at least seven (7) years of related experience; relevant industry experience strongly preferred
Demonstrated experience leading late-stage clinical and commercial process development activities for biopharmaceutical manufacturing processes including process characterization process robustness scale-up and definition of manufacturing operation ranges
Experience with scalable upstream and/or downstream unit operations commonly used in cell manufacturing (e.g. multi-layer culture vessels bioreactors media manufacturing platforms automated cell washing and concentration fill/finish)
Strong understanding of Quality by Design process validation and GMP manufacturing requirements with experience translating process development knowledge into strategies that support technology transfer PPQ control strategy and commercial manufacturing
Experience partnering with MSAT Manufacturing Quality Analytical Development and other cross-functional teams to advance processes from development through technology transfer and GMP manufacturing
Demonstrated ability to develop and defend technical strategies using scientific and engineering principles including interpretation of complex process data and application of statistical/design of experiments approaches
Strong written and verbal communication skills with the ability to effectively communicate technical strategies process understanding risks and recommendations to a range of technical and business stakeholders (both internal and external)
Demonstrated ability to mentor and develop other engineers and scientists and contribute to the advancement of process development practices and technical capabilities within the organization
Strong problem-solving and organizational skills with demonstrated ability to manage multiple technical projects independently reassess priorities as needs evolve and adjust plans in a timely disciplined manner while maintaining alignment with stakeholders quality standards and project commitments
Ability to provide flexible support for time-sensitive process development activities outside of standard business hours including evenings weekends and holidays as needed
Ability to maintain a regular laboratory presence and provide active hands-on support for experimental execution as required by project needs
Ability to occasionally lift up to 50 pounds
Ability to work with hazardous materials (i.e. chemicals electrical equipment and human tissue) without endangering oneself or others
Ability to wear standard laboratory PPE

Preferred Qualifications

Experience developing manufacturing processes for cell-based products; previous experience with iPSC-derived cell types is a plus.
Experience with and understanding of a variety of common analytical methods used to assess cell growth and differentiation including cell counting metabolite analysis flow cytometry PCR and microscopic imaging
Experience working within a regulated environment with a strong understanding of expectations and best practices
Experience working with or within a contract development and manufacturing organization (CDMO)

EEO Information

Fujifilm is committedto providing equal opportunities in hiring promotion and advancement compensation benefits and training regardless of nationality age gender sexual orientation or gender identity race ethnicity religion political creed ideology national or social origin disability veteran status etc.

ADA Information

If you require reasonable accommodation in completing this application interviewing completing any pre-employment testing or otherwise participating in the employee selection process please direct your inquiries to our HR Department ().

Required Experience:

Senior IC

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