Computer/Automation Validation Consultant – Fremont, CA

Oct 31, 2019   //   by crosado   //   Job Opportunities  //  Comments Off on Computer/Automation Validation Consultant – Fremont, CA

BioPharma Consulting JAD Group is in need of an Automation Consultant with experience on Delta V for one of our clients in California.

Tittle: Automation Consultant

Duration: 1 year

Location: Fremont, CA

Required Skills:

The consulting activities to be performed require resources with experience in the following disciplines:

  1. Qualification Activities in a GMP regulated environment
  2. Equipment Qualification
  3. Computer System Validation
  4. Preparation of Validation Protocols (IQ, OQ, PQ, CSV, etc.), and SOPs.
  5. CSV, GAMP-5 and 21 CFR Part 11 for Automated/Computerized Systems Validations.
  6. Support for generation of documents such as:
  • Standard Operating Procedures (SOP)
  • Preventative Maintenance (PM)
  • Spare Parts List
  • Specifications

Job Description:

Consulting Services to support for the following:

  • DeltaV – Generation and execution of commissioning documents and associated and reports to relocate a Sartorius Freeze Thaw Unit
  • Siemens BMS – Generation and execution of decommissioning documents and associated reports
  • OSI PI – Generation and execution of commissioning documents and associated reports
  • Generation, revision and approval of specification documents and any applicable Automation Department Standard Operation Procedures (SOPs).

Scope: The Consultant will be providing direct support to the Automation team and Engineering Department.  The Automation Consultant resource will meet with the stockholders to gather required data to generate required deliverables and to meet milestone dates.

The documents to be generated and executed include, but are not limited to:

  1. Commissioning IV / OV
  2. Decommissioning Documents
  3. Deviations
  4. SOP generation or revision of existing
  5. Design Specification generation or revision of existing
  6. Drawing verification at the field
  7. WO generation and closing
  8. Change Control Task closing

For further details or questions, please submit your inquiries and/or your updated resume to: info@bpc-jadgroup.com

Comments are closed.