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CAD Specialist

Location Novato, California
BioMarin is the world leader in delivering therapeutics that provide meaningful advances to patients who live with serious and life-threatening rare genetic diseases. We target diseases that lack effective therapies and affect relatively small numbers of patients, many of whom are children. These conditions are often inherited, difficult to diagnose, progressively debilitating and have few, if any, treatment options. BioMarin will continue to focus on advancing therapies that are the first or best of their kind.

BioMarin’s Technical Operations group is responsible for creating our drugs for use in clinical trials and for scaling production of those drugs for the commercial market. These engineers, technicians, scientists and support staff build and maintain BioMarin’s cutting-edge manufacturing processes and sites, provide quality assurance and quality control to ensure we meet regulatory standards, and procure the needed goods and services to support manufacturing and coordinating the worldwide movement of our drugs to patients. Come join our team and make a meaningful impact on patients’ lives.

SUMMARY

This position functions as a CAD drafter and documentation specialist for the Engineering Documentation Control group at BioMarin, USA. The candidate will assist the Engineering Documentation Supervisor in maintaining an organized and accurate set of AutoCAD drawings and documents for facilities, utilities, and equipment for both GxP and non GxP facilities. The candidate will create new drawings and revise existing drawings that will be controlled within the Engineering Document Control System. This position will also provide document support for all other documents managed by Engineering Document Control.

RESPONSIBILITIES

The Engineering Documentation Control Specialist will be responsible for the following with little supervision:

  • Review and verify all new and revised drawings for content, accuracy, and to ensure that formatting meets BioMarin Engineering Documentation requirements.
  • Update drawings with the use of submitted red-lined drawing submittals and publish the redlines according to SOP Requirements.
  • Perform walkdowns to confirm accuracy of red-lined as-build drawing submittals.
  • Create system drawing sets by using legacy engineering and project drawings.
  • Traveling between BioMarin Novato and San Rafael sites to aid in engineering documentation needs, project support, and perform field verifications.
  • Reviewing, logging, and updating documentation service requests in the documentation database for tracking purposes.
  • Working in coordination with BioMarin personnel according to Engineering Documentation needs and attending Project meetings as needed to represent the EDC Department.
  • Working within BioMarin’s validated SharePoint electronic documentation system and within the standard Shared Drive locations for drawing management.
  • Assist the Engineering Document Supervisor with document control policies and processes, document storage, retrieval, drawing revisions and new document generation as needed.
  • Assist with running day-to-day operation of the digital and physical engineering document library including receiving new Turnover Documentation as well as organizing existing records
  • Perform action items within the TrackWise quality system for EDC related tasks.
  • Performing other engineering documentation duties as needed such as running reports, presenting metrics, updating web pages, and supporting printing requests from other departments.
  • Other duties as assigned by management.

EXPERIENCE

Desired Skills:

  • At a minimum the candidate will have 5 or more years of CAD experience working within an engineering field. The candidate will have a full understanding of major building, utility and control systems, as well as process equipment.
    • Education levels and training (certifications) received will be considered in lieu of experience levels.
  • At a minimum the candidate will have 2 to 3 years of experience working in a cGMP controlled engineering document environment within the biotech or pharmaceutical field.
    • Education levels and training (certifications) received will be considered in lieu of experience levels.
  • Preferably the candidate will have experience using SharePoint document management software or an equivalent such as Documentum or OneSource.
  • Meridian Document Management System experience a plus.

EDUCATION

  • Minimum of Associate degree in an engineering field.
    • A combination of on the job trainingand previous experience will be considered.
  • AutoCAD 2012 Certified Professional or equivalent.

We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, sexual orientation, national origin, disability status, protected veteran status, or any other characteristic protected by law.

About our location

Novato

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We treat rare diseases, and that gives us rare opportunities. Chris Brodeur, Director, Corporate Compliance
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