Lead Process Engineering Specialist
2 weeks ago
Overview
The Lead Process Engineering Specialist serves as a key representative of the technical operations division, engaging with clients, regulatory bodies, and internal management. This role is positioned within the Process Sciences sector of FUJIFILM Holdings America Corporation.
Key Responsibilities:
- Oversee technical transfer and process validation for client projects, ensuring seamless integration into manufacturing.
- Exercise independent judgment in complex engineering challenges.
- Provide technical guidance for capital projects, leveraging expertise to enhance project outcomes.
- Conduct assessments for new project site-fit as required.
- Apply engineering design principles to optimize processes.
- Demonstrate proficiency in troubleshooting production issues.
- Identify and implement process enhancements.
Required Expertise:
- In-depth understanding of biotechnology, bio-production, and related technologies, including fermentation, cell culture, and purification of biopharmaceuticals.
- Proven experience in Tech Transfer or Process Validation within the biopharmaceutical sector.
- Adept at utilizing advanced computer systems and instrumentation for data analysis in complex scenarios.
- Possess advanced scientific and engineering knowledge applicable to larger, intricate projects.
Strategic Development:
Formulate and execute strategies to enhance processes and ensure compliance with both internal and regulatory standards. Collaborate effectively across various company functions to address challenges and seize opportunities.
Supervision and Collaboration:
Operate with minimal oversight on complex projects, providing mentorship to junior colleagues. Act as a resource within the department, sharing innovative ideas and research findings.
Problem-Solving Skills:
Develop and implement technical solutions, benchmarking technologies against industry standards. Contribute valuable technical insights to team problem-solving efforts.
Communication Proficiency:
Draft, edit, and review standard operating procedures (SOPs) and technical documentation. Engage in direct communication with clients and regulatory agencies to address technical matters and resolve issues.
Background Requirements:
Possess a Bachelor's degree with a minimum of 7 years of relevant experience, or a Master's degree with at least 5 years of experience. A PhD with GMP experience is also acceptable.
Shift Requirements:
This position may require activities outside of standard business hours to support the 24-hour operations of the Process Sciences department.
FUJIFILM Holdings America Corporation is committed to equal opportunity employment. All qualified applicants will be considered without regard to race, color, religion, sex, national origin, disability, protected veteran status, sexual orientation, gender identity, or any other protected class.
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