FUJIFILM

Staff Process Engineer

Job Locations US-NC-Research Triangle Park
Posted Date 3 weeks ago(4/19/2021 11:51 AM)
Requisition ID
2021-14846
Category
Manufacturing
Company (Portal Searching)
FUJIFILM Diosynth Biotechnologies U.S.A., Inc.

Overview

The Staff Process Engineer, (internally known as Staff Validation Engineer) is a high-level position in the MT&S department of FDBU.  This position will directly report to the Associate Director of Manufacturing Technology and Support, but may also have a functional reporting relationship to a senior colleague on a project to project basis.

External US

The Staff Process Engineer, (internally known as Staff Validation Engineer) is a high-level position in the MT&S department of FDBU.  This position will directly report to the Associate Director of Manufacturing Technology and Support, but may also have a functional reporting relationship to a senior colleague on a project to project basis.

 

MAJOR ACTIVITIES AND RESPONSIBILITIES:

  • Identify process improvements and implement using problem analysis tools
  • Work under minimal supervision on complex projects and may assist/direct less experience peers (20%)
  • Wide latitude for independent judgment (5%)
  • Support capital projects by providing technical expertise (10%)
  • Manage large complex engineering projects (10%)
  • Demonstrate supervisory skills with outside contractors and consultants (5%)
  • Apply engineering design principles (10%)
  • Demonstrate production troubleshooting knowledge (10%)
  • Support development of engineering and technology transfer policies (5%).
  • Prepare and deliver presentations to external audiences (10%)
  • Identify process improvements and implement (10%)
  • Other duties as assigned (5%)

 

SCOPE MEASURES:

  • The Staff Validation Engineer will be expected to attend all internal hands-on training for the SOP’s in the curriculum assigned to the position

 

BACKGROUND REQUIREMENTS:

Education/Experience:

  • B.Sc. degree or equivalent and 10+ years of relevant experience.

 

GMP Experience:

  • Senior Validation Engineer is a high-level position in the Validation/Technical Operations department of FDBU, a minimum of ten years of GMP experience is required.

 

Shift:

  • The Technical Operations department provides 24 hour support to manufacturing. Execution of activities may be required outside of core business hours.

 

The Major Equipment and Systems that are supported include:

  • DCS manufactured by Asea Brown Boveri (ABB).
  • Fermentation and Cell Culture reactors manufactured by Applikon and Braun.
  • Recovery centrifuges manufactured by Westfalia and Carr.
  • LPC Skids manufactured by GE Healthcare.
  • UFDF/NFF Skids manufactured by Millipore and Pall.
  • Single Use Equipment manufactured by various vendors, including Xcellerex (GE) and Sartorius.
  • Delta V 
  • TFF Single Use using Wonderware software
  • Unicorn Software 
  • PI History and process trending, where applicable
  • Single Use Bulk Fill System

 

Ability to work in a cross functional team environment

 

FDBU works with technical data, technology and materials that are subject to U.S. export laws and regulations. This position will require access to technical data, technology and source code that is controlled under U.S. export laws and regulations, including but not limited to the International Traffic in Arms Regulations at 22 C.F.R. Parts 120 – 130 and Export Administration Regulations in 15 C.F.R. Part 730 – 774, as may be amended. To conform to these laws and regulations, applicants must be U.S. citizens, lawful permanent residents of the U.S., protected individuals as defined by 8 USC 1324(b)(a)(3) (i.e., asylees and refugees) or otherwise eligible for an export authorization from the U.S. Department of State or U.S. Department of Commerce. Offers of employment will be contingent on the Company’s ability to secure an export authorization. FDBU is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, protected veteran status, sexual orientation, gender identify or any other protected class.

 

FDBU is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, protected veteran status, sexual orientation, gender identify or any other protected class.

 

To all agencies: Please, no phone calls or emails to any employee of FUJIFILM about this requisition. All resumes submitted by search firms/employment agencies to any employee at FUJIFILM via-email, the internet or in any form and/or method will be deemed the sole property of FUJIFILM, unless such search firms/employment agencies were engaged by FUJIFILM for this requisition and a valid agreement with FUJIFILM is in place. In the event a candidate who was submitted outside of the FUJIFILM agency engagement process is hired, no fee or payment of any kind will be paid.

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