Documentation Specialist

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