Documentation Specialist III Hybrid Remote

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 BI Engineering Drawing Management System (EDMS)

Download, upload, update, start/complete tasks and otherwise maintain drawings and data in the BI EDMS system. (Specifically, Siemens COMOS)

Maintains and Completes Work Orders in BI s task management system (MAXIMO)

Work Order tracking at BI 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 BI Engineering Documentation

A weekly meeting may be conducted to assign workload to the service provider, as well as address task-related questions.

BI Intellectual property

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

Requirements

Maintenance of a BI network account

Continuous on-time completion of all assigned training

Computing Equipment

Service provider must maintain one or more BI-issued personal computers

Collaboration

Service provider must collaborate within the confines of the BI communication channels only (e.G., BI 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 BI computer account and equipment must complete all assigned training in the BI LOS (Learning One Source system) by the due date for compliance.

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

Required Skills:

BIOPHARMACEUTICAL

DOCUMENT MANAGEMENT SYSTEM

GMP

AUTOCAD

DRAFTING

Additional Skills:

DOCUMENTATION

MAINTENANCE

LIFE SCIENCE

BUSINESS INTELLIGENCE

MICROSOFT TEAMS

EDMS

CAD

REDLINE

INTELLECTUAL PROPERTY

COMPUTER AIDED DESIGN

MAXIMO

ENGINEERING DOCUMENTATION

AUTO CAD

DATABASE