Sr. Design Engineer (Electronic Batch Record)

Company Info
Johnson Service Group
Atlanta, GA, United States

Phone: 678-564-5698
Web Site: www.jsginc.com

Company Profile
col-narrow   

Title:

Sr. Design Engineer (Electronic Batch Record)

Location:

Santa Monica, CA 

Job ID:

58334
col-wide   

Job Description:

Do you want to make a real difference in the world? Come help our client in their quest to cure cancer! Everyone is grounded by this common goal. Every single day they seek to establish a direct line between that purpose and their day-to-day work. Join them in their mission!

Our client is seeking a Senior Design Engineer (a Senior Manager level individual contributor) to develop the Electronic Batch Record system for their manufacturing network. This is a direct hire position located in Santa Monica, CA. Relocation assistance is available.

Job Responsibilities
  • Creates process maps / models working with manufacturing and engineering disciplines
  • Creates data flow diagrams documenting interactions with manufacturing systems, such as ERP (Oracle EBS) Manufacturing floor equipment, Automation Systems
  • Creates MES Basic Functions using process flow maps
  • Creates 'Test Harness' MBRs / GMBRs to test Basic functions
  • Authors Basic Function Functional Design Specifications
  • Designs GMBRs / MBRs, Creates Parameterized Value Lists (PVLs) with harmonization and standardization in mind
  • Creates SDLC documentation for GMBRs following GMP / GDP guidelines
  • Creates Equipment Lifecycle flow diagrams and Equipment state diagrams working with a team
  • Collaboratively defines and configures Master data in Werum PAS X
  • Collaborates with Manufacturing and Quality teams to Validate MBRs
  • Creates standard design rules for MBR creation and gains team ‘buy-in’
  • Advises on standard methodologies for library element creation / GMBR creation
  • Migrates MBRs between different environments, writes standard operating procedures for migrating GMBRs/PVLs
Required Skills and Experience
  • 6+ years of relevant experience an MS degree
  • 8+ years of relevant experience and a BS or BA.
  • 10+ years relevant experience with an AS degree.
  • Hands on Werum PAS X MBR design knowledge and broad Werum PAS X knowledge desirable.
  • Non-Werum MES batch record design experience at minimum, is required.
  • Process Engineering experience in a biotech or pharma setting is required, preferably in Cell Therapy / CAR T domain
  • Ability to Model Manufacturing Process (Lead Process Mapping exercises / Create Process Maps / Process Models)
  • Ability to articulate Manufacturing Process interactions with Manufacturing Systems (such as ERP, Instruments) and document data exchange
  • Experience with Process Equipment and Process Automation Systems in MES context
  • Deep Master Batch Record design expertise demonstrated with formal training and experience
  • Thorough understanding of Master Data in MES Context, ability to define master data while working with a team from manufacturing/ engineering/ materials management/ supply chain
  • Experience with Oracle EBS integration to Werum PAS X preferred (integration from PAS X to non-Werum platforms also acceptable)
  • Experience creating MBR library objects that can be validated once, then referenced / reused in several GMBRs is benefit
  • Experience writing standards for MBR design is also a plus