Advanced Process Sciences Engineer

2 weeks ago

Durham, North Carolina, United States FUJIFILM Corporation Full time
Position Overview
The Lead Process Engineering Specialist serves as a key representative of the technical operations division for FUJIFILM Corporation, engaging with clients, regulatory bodies, and internal management. This role is situated within the Process Sciences department and is considered a mid-level position.

This position will report directly to the US/DS Manager of Process Sciences, while also collaborating with senior colleagues on various projects.


KEY RESPONSIBILITIES:
- Oversee the technical transfer and process validation of client projects into manufacturing as required.
- Exercise independent judgment in decision-making.
- Provide technical expertise to support capital projects.
- Address and resolve complex engineering challenges.
- Conduct site-fit assessments for new projects as necessary.
- Implement engineering design principles effectively.
- Exhibit proficiency in production troubleshooting.
- Identify and execute process enhancements.

REQUIRED SKILLS:


- Strong understanding of biotechnology, bio-production, and related technologies, including fermentation, cell culture, and purification of regulated biopharmaceuticals.

- Experience in Tech Transfer or Process Validation of biopharmaceutical processes.
- Ability to apply advanced computer systems and data analysis to intricate situations.
- Demonstrated scientific and engineering expertise on larger, more complex projects.

- Develop and implement strategies to enhance processes and ensure compliance with both internal and regulatory standards.

- Collaborate effectively across various company functions to identify and address challenges and opportunities.

- Capable of devising facility fit strategies based on limited client information.

SUPERVISION:
- Operate with minimal supervision on intricate projects and provide guidance to less experienced colleagues.
- Serve as a resource for team members within the function.
- Present innovative ideas and research findings.
- Collaborate with cross-functional teams to tackle problems or develop new products.

PROBLEM SOLVING:
- Formulate technical and system solutions.
- Benchmark available technologies against industry standards.
- Implement new technologies within the department.
- Provide valuable technical insights during team problem-solving sessions.
- Contribute to decision-making based on technical information.

- Maintain a solid grasp of current research literature in the scientific field; stay updated on trends through journals and professional networks.


COMMUNICATION SKILLS:
- Draft, edit, and review standard operating procedures (SOPs) and protocols.
- Author and review qualification, validation, and tech transfer documents.
- Prepare departmental and inter-departmental reports for both internal and external audiences.
- Facilitate cross-functional communication within FUJIFILM Corporation.
- Engage directly with clients to discuss technical matters and resolve issues.
- Communicate with regulatory agencies and industry experts.
- Significantly influence departmental performance and outcomes through personal contributions and leadership.

EDUCATIONAL AND EXPERIENCE REQUIREMENTS:
- Bachelor’s degree with 7+ years of relevant experience or equivalent.
- Master’s degree with 5+ years of relevant experience or equivalent.

ADDITIONAL REQUIREMENTS:
- A minimum of five years of experience in a GMP environment is essential.

SHIFT REQUIREMENTS:
- The Process Sciences department operates 24/7 to support manufacturing activities, which may require work outside standard business hours.
- This position involves access to technical data and materials governed by U.S. export laws and regulations. Applicants must meet eligibility criteria for access to controlled technology.
- FUJIFILM Corporation is an Equal Opportunity Employer, ensuring fair consideration for all qualified applicants regardless of race, color, religion, sex, national origin, disability, protected veteran status, sexual orientation, gender identity, or any other protected class.

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