Fujifilm Manufacturing USA, Inc

Manager, Process Engineering

Fujifilm Manufacturing USA, Inc • $100K — $130K *
Holly Springs, NC 27540In-Person
Pharmaceuticals & Biotech
5 - 7 years of experience
Today
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Job Overview by Ladders

Qualifications

  • Bachelor's or Master's degree in engineering or related field.
  • Minimum 6 years engineering experience, 4+ in life sciences.
  • 4+ years managing teams in engineering roles.
  • Experience in Greenfield site startup.
  • Hands-on experience with cell culture, centrifugation, chromatography, TFF, and depth filtration.

Responsibilities

  • Lead the Upstream and Downstream Drug Substance Manufacturing Process Engineering team.
  • Foster a culture of respect and support through servant leadership.
  • Implement Process Engineering strategy in collaboration with stakeholders.
  • Oversight of department operations, including budget and resource planning.
  • Drive optimization of manufacturing processes and equipment usage.
  • Define equipment requirements for client manufacturing processes.
  • Translate complex process data into clear technical updates.

Benefits

  • Opportunity to lead a high-performing team in a dynamic environment.
  • Focus on continuous learning and professional development.
  • Engagement in strategic collaborations with diverse stakeholders.
  • Involvement in cutting-edge technology introductions.
  • Chance to impact manufacturing processes at a large scale.
Full Job Description
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.

Job 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:
  • Bachelor's degree in engineering or related discipline with 6+ years in
    an engineering role (4+ in the life science industry); or Master's 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


About Fujifilm Manufacturing USA, Inc

Fujifilm Manufacturing USA, Inc is a subsidiary of Fujifilm Holdings Corporation, a Japanese multinational conglomerate that specializes in imaging and photography. Fujifilm Manufacturing USA, Inc is responsible for the manufacturing of photographic paper, film, and other imaging products in the United States. The company was established in 1988 and has its headquarters in Valhalla, New York. Fujifilm Manufacturing USA, Inc operates as a subsidiary of Fujifilm North America Corporation.
Learn more about Fujifilm Manufacturing USA, Inc
Size
72,332 employees
Industry
Manufacturing & Automotive
NASDAQ
FUJIF
* Ladders Estimates

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