Manager, Process Engineering

Fujifilm

Job Location:

Holly Springs, MS - USA

Monthly Salary: Not Disclosed

Posted on: 3 days ago

Vacancies: 1 Vacancy

Department:

Engineering

Job Summary

Position Overview

The 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 Manager utilizes their technical expertise with process equipment and processes to provide support and direction on technical topics. This role applies their leadership experience to oversee and manage a team of experienced and developing engineers supporting operations technology transfers (TT) and projects on time and within budget. Additionally the Manager drives site engineering goals and deliverables ensuring the successful manufacturing operations.

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

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 close 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
Manages a team to lead 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 validatio
Provides leadership and direction to the manufacturing site to define the equipment requirements for execution of clients manufacturing processes
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 as needed
Participates in TT stage gate reviews on incoming processes/changes ensuring the change is ready for introduction to manufacturing and
manufacturability of the process
Establishes systems and procedures to enable proactive equipment monitoring analysis and reporting
Functions as the senior leader for client projects translating complex process data into clear and concise technical explanations and status updates and supports equipment evaluations and risk assessments
Provides team support for critical manufacturing investigations and technical oversight of deviations change controls corrective and preventive
actions (CAPAs)
Assesses communicates and mitigates key manufacturing equipment risks
Oversees process engineering process equipment instrument care maintenance troubleshooting and data interpretation
Evaluates team performance 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 managing people
Prior experience in Greenfield site startup
Prior experience in cell culture centrifugation chromatography TFF and depth filtration
Experience working in a changing project driven organization

Preferred Requirements:

Large capital expenditure experience
Prior experience working in a Greenfield site
Experience collaborating with global colleagues

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:

Manager

Position OverviewThe 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 Manager utilizes their technical expertise with process equipment and processes...