- Master's Degree
- Associate's Degree
- Bachelor's Degree
- Process Engineering
- Supply Chain Experience
- Benefits Administration
- Oracle EBS
Do you want to make a real difference in the world? Come help us in our quest to cure cancer! Everyone at Kite is grounded by this common goal. Every single day, we seek to establish a direct line between that purpose and our day-to-day work. Join us in our mission!
We are seeking a Senior Design Engineer (a Senior Manager level individual contributor) to develop the Electronic Batch Record system for Kite’s manufacturing network.
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