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Senior Manager, Process Engineering

Job Location:

Holly Springs, MS - USA

Monthly Salary: Not provided by the employer

Posted: 1 September 2026 (7 hours ago)

Application Deadline: 29 November 2026

Vacancies: 1 Vacancy

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Department:

Job Summary

Position Overview

The Senior Manager Process Engineering is responsible for leading the Upstream and Downstream Drug Substance Manufacturing (DSM) Process Engineering team and activities from inoculation through bulk fill. The Senior Manager utilizes their technical expertise with processequipment and processes to provide support and direction on technical topics. This role applies their leadership experience to oversee and lead a team of experienced and developing engineers supporting operations technology transfers (TT) and projects on time and within
budget. This role supports TT end-to-end introduction of client processes into the site from receipt of the process package through engineering runs process fit and gap assessment facility fit TT protocol execution and successful PPQ. The Senior Manager drives site
engineering goals and deliverables ensuring the successful manufacturing operations. Additionally this role is the single accountable owner for transfer schedule transfer risk and the technical integrity of what is handed to Manufacturing. This is a client-facing role.

Company Overview

FUJIFILM Biotechnologies is building the future of bioproduction in Holly Springs North Carolina. By end of 2025 well open North Americas largest end-to-end CDMO biopharmaceutical manufacturing facility offering drug substance production fill-finish and packaging under one roof.

Were looking for passionate mission-driven people to help us realize this exciting vision and deliver the next vaccine cure or therapy. We offer a dynamic work environment and were proud to cultivate a culture that will fuel your purpose energy and drivewhat we call Genki. Ready to shape the future of medicine Lets transform healthcare together!

Holly Springs North Carolina combines small-town warmth with proximity to Raleighs thriving tech scene making it the perfect blend of community and opportunity.

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

What Youll Do:

Fosters and sustains a people first culture where the team feels valued respected and supported through servant leadership
Implements the strategy for Process Engineering in collaboration with stakeholders and Large-Scale Business Unit counterparts
Builds and leads a high-performing Process Engineering team while encouraging a culture that prioritizes continuous learning and development through coaching and mentoring
Owns departmental operations budget systems workflows and resource planning to deliver on time and within budget
Leads a team to develop and implement technically sound and fit-for-purpose policies and procedures based on current regulations industry standards and practices for DSM process and TT and equipment validation
Provides leadership and direction to the manufacturing site defining equipment requirements for execution of clients manufacturing processes
Establishes process excellence by defining and optimizing upstream mammalian cell culture and downstream purification standards; identifying and justifying CPPs CQAs CMAs and design space concepts
Seeks to continuously optimize the manufacturing processes and equipment to ensure effective use of capacity and minimize costs
Partners with Client MSAT Quality and Manufacturing on new technology introduction scale-up and manufacturability as part of TT
Participates in TT stage gate reviews on incoming processes/changes ensuring the change is ready for introduction to manufacturing and manufacturability of the process
Develops and defends scale-up/scale-down rationales executes process and facility fit assessment against installed equipment envelope
Establishes systems and procedures to enable proactive equipment monitoring analysis and reporting
Functions as the senior technical leader to clients and key stakeholders and communicating status risk and technical updates
Leads team through high-quality and critical manufacturing investigations deviations change controls corrective and preventive actions (CAPAs)
Drives manufacturing reliability and robustness by overseeing equipment and instrument care maintenance troubleshooting and right-first time through data-driven practices
Evaluates team performance develops and implements measures to improve productivity and engagement and partners with People & Culture to recruit and retain talent
Performs other duties as assigned

Minimum Requirements:

Bachelors degree in engineering or related discipline with 6 years in an engineering role (4 in the life science industry); or Masters degree in engineering or related discipline with 4 years in an engineering role in the life science industry
4 years of experience supervising/managing other supervisors/managers or demonstrated progressive leadership experience through people management and/or
leading complex projects or programs technical initiatives or cross-functional teams. Experience coaching mentoring influencing or directing the work of others may serve as a substitute
Prior experience in Greenfield site startup
Prior experience in cell culture centrifugation chromatography TFF and depth filtration
Experience leading others in a pharmaceutical/biological manufacturing facility
Experience working in a changing project driven organization

Preferred Requirements:

Experience with regulatory inspections investigations and
change management
Experience in pharmaceutical/biological manufacturing
operations and familiar with GMP/GLP requirements

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 Manager

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About Company

Fujifilm

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