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Job: *Contract* Document Management Specialist (Engineering), FUJIFILM Diosynth Biotechnologies, Morrisville, NC

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General Information


Job title:
*Contract* Document Management Specialist (Engineering)
Job location:
Morrisville, NC  27560 United States
Requisition code:
Date posted:
11/12/2020
Compensation:
Job category:
Administrative
Employment type:
Contractor

Job Description


The work we do at FUJIFILM Diosynth Biotechnologies has never been more important—and we are looking for talented candidates to join us. We’re growing our locations, our capabilities, and our teams, and looking for passionate, mission-driven people like you who want to make a real difference in people’s lives. Join FDB and help create the next vaccine, cure, or gene therapy in partnership with some of the most innovative biopharma companies across the globe. Here, you’ll work alongside and learn from some of the most dedicated scientists, engineers, and manufacturers in the industry. We’re proud to cultivate a culture that will fuel your passion, energy, and drive—what FDB calls Genki. Join us and discover a community that thrives on diversity and never scares away from a complex challenge. At FDB, you determine what’s possible.

The Engineering department at FDBU is seeking a contract Document Management Specialist.  This is a support position in Engineering with the primary purpose of managing and coordinating all engineering documentation to include but not limited to facility, utility, and equipment specifications, equipment operating manuals, drawings, engineering project turnover packages (ETOP), and qualification documentation.  The documentation can be either paper based or electronic.  The Engineering Document Specialist is expected to perform the primary responsibilities in support of the engineering department as well as other functions on site as required. There are no benefits associated with this position.   

This position will work directly under the guidance of a senior level engineer or manager within the Engineering Department.

Essential Job Duties and Responsibilities:

The Document Management Specialist must be able to perform the following essential duties and responsibilities for processing and control of all technical documents for engineering as well as other FDBU functions.

Work independently
Maintain compliant cGMP training
Process and Control cGMP required engineering documents
Review documents for format, numbering, and good documentation practices
Ensure compliance with applicable SOPs
SOP revisions for governing engineering documentation as required
Facilitate the review and approval process with document authors and reviewers via DocuSign and archiving in Sharepoint to make available online
Convert paper documents to electronic media via scanning and Adobe Acrobat as required to optimize vault storage
Work with authors to perform editing during review and approval process
Maintain tracking and status for documents being processed
Obtain client approvals and contact clients as needed for other documentation related purposes
Maintain master lists of documents and provide information online
Ensure copies of documents are delivered to users and superseded and obsolete documents are removed from use
Maintain engineering document vault (both paper and electronic media) in accordance with site guidelines and procedures
Assist with government and client audits by providing requested documents and fielding questions related to engineering document control
Assist other functions with requested information within engineering documentation
Provide training for engineering document control procedures
Maintain online access to documents and technical information related to engineering documentation
Update manuals and project information as needed
Adhere to all safety requirements and follow safe procedures immediately notifying management or Safety of any unsafe condition or potential hazard
Attend all required EHS training
Other duties as assigned
 

BACKGROUND REQUIREMENTS:

AAS degree and 2 – 4+ years relevant experience. Previous work experience in a regulated (FDA, NRC, etc.) environment.
Good working knowledge of cGMP requirements
General knowledge of engineering documentation required.
Proficient computer skills with experience using MS Office software (Word, Excel, PowerPoint, Access) and other software applications typically used in an office work environment.
AutoCAD experience a plus
Must be competent in proofing and editing technical documents for structure and organization
Excellent organizational, verbal and written communication skills with the ability to effectively communicate within cross-functional teams and to management
Ability to create original documentation using own and/or other’s data, combining data and text into clear, logical, and comprehensive communications
Excellent interpersonal skills and ability to work effectively and efficiently in a team-based environment with employees at all levels
Self-starter and able to work independently

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.

Job Requirements


BACKGROUND REQUIREMENTS:

AAS degree and 2 – 4+ years relevant experience. Previous work experience in a regulated (FDA, NRC, etc.) environment.
Good working knowledge of cGMP requirements
General knowledge of engineering documentation required.
Proficient computer skills with experience using MS Office software (Word, Excel, PowerPoint, Access) and other software applications typically used in an office work environment.
AutoCAD experience a plus
Must be competent in proofing and editing technical documents for structure and organization
Excellent organizational, verbal and written communication skills with the ability to effectively communicate within cross-functional teams and to management
Ability to create original documentation using own and/or other’s data, combining data and text into clear, logical, and comprehensive communications
Excellent interpersonal skills and ability to work effectively and efficiently in a team-based environment with employees at all levels
Self-starter and able to work independently

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.
(Job number: 3958497)
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