Documentation Specialist

3 weeks ago

Fremont, United States eTeam Full time

Job Title: Documentation specialist III - AutoCAD

Location: Fremont, CA (Remote)

Duration: 6 months


Must have skills:

  • Expert knowledge in AutoCAD and design
  • Site facility knowledge
  • Experience in GMP manufacturing facilities
  • An ability to read, understand and modify Engineering drawings, including P&ID’s


Work hours

  • Collaborative work must be performed in Pacific Time zone between the hours of 8am to 5pm
  • Service provider must be in proximity of the US Biopharma site in Fremont, CA
  • Ability to travel to site on same-day notice


Work location

  • The majority of the work is expected to be able to be performed remotely. On-site visits may be required on an ad-hoc basis, on same-day notice.


Duties:

  • The US Biopharma E&T (Engineering & Technology) Department is seeking a service partner to support revisions to our Facility and Engineering Drawings and Documentation database.
  • These drawings are very critical to the site for design and maintenance activities.
  • The drawings are maintained electronically in our CAD (Computer Aided Design) database.
  • The department has a fluctuating amount of CAD work in support, driven by facility changes (CapEx projects), ranging from a few hours per week, to 40-60 hours at peak demand.
  • Engaging an external partner with the necessary technical capabilities would allow the organization to address demand flexibly.
  • The business is located in Fremont, CA, and engages in the manufacture of biologic medicines, governed under FDA, EMA and other regulations.


Work Description

Perform requested updates to Engineering Drawings

  • Make changes to engineering drawings using AutoDesk AutoCAD or other drafting/modeling programs, to the specifications of the drawing project or redline documents.
  • Maintain drawings in the client's Engineering Drawing Management System (EDMS)
  • Download, upload, update, start/complete tasks and otherwise maintain drawings and data in the client EDMS system. (Specifically, Siemens COMOS)
  • Maintains and Completes Work Orders in client’s task management system (MAXIMO)
  • Work Order tracking at client is accomplished via the “Maximo” application and requires some manual input.
  • Complete requested work in a timely manner
  • Work will typically be expected to be completed within a regular schedule, but may include rushed/ time sensitive requests, which will require immediate attention and turnaround.
  • Maintain Open communication with client Engineering Documentation
  • A weekly meeting may be conducted to assign workload to the service provider, as well as address task-related questions.

Client Intellectual property

  • Drawings may contain Client intellectual property and therefore must be treated as such. All Client files must be kept in a secure file system and may not be disseminated to unapproved individuals or organizations.

Requirements

  • Maintenance of a Client network account
  • Continuous on-time completion of all assigned training


Computing Equipment

  • Service provider must maintain one or more Client-issued personal computers


Collaboration

  • Service provider must collaborate within the confines of the Client communication channels only (e.g., Client email, MS Teams, Engineering Document Management System, etc.)
  • Works under minimal technical supervision from client


Task Management

  • Work tasks may be communicated at any time during the week


Training

  • Vendor personnel furnished with a client computer account and equipment must complete all assigned training in the client LOS (Learning One Source system) by the due date for compliance.


Education:

Bachelor's Degree in Engineering - Three to five years of experience in related Life Science industry - Good knowledge and understanding of biopharmaceutical industry and AutoCAD experience

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