- 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.
- 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 Engineering Drawing Management System (EDMS): Download, upload, update, start/complete tasks and otherwise maintain drawings and data in the EDMS system. (Specifically, Siemens COMOS)
- Maintains and Completes Work Orders in BI's task management system (MAXIMO): Work Order tracking at 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 Engineering Documentation: A weekly meeting may be conducted to assign workload to the service provider, as well as address task-related questions.
- Intellectual property : Drawings may contain intellectual property and therefore must be treated as such. All files must be kept in a secure file system and may not be disseminated to unapproved individuals or organizations.
- 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
- 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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Documentation Specialist III - Fremont, United States - US Tech Solutions
Description
******* 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:
Work Description
Requirements
Maintenance of a network account: Continuous on-time completion of all assigned training
Computing Equipment: The service provider must maintain one or more BI-issued personal computers
Collaboration: Service provider must collaborate within the confines of the communication channels only (e.g., email, MS Teams, Engineering Document Management System, etc.)
Works under minimal technical supervision from BI
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.
Task Management: Work tasks may be communicated at any time during the week
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
Training: Vendor personnel furnished with a computer account and equipment must complete all assigned training in the LOS (Learning One Source system) by the due date for compliance.
Skills:
Education:
About US Tech Solutions:
US Tech Solutions is a global staff augmentation firm providing a wide range of talent on-demand and total workforce solutions. To know more about US Tech Solutions, please visit ) .
US Tech Solutions is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.
