Job Description :
Job Title: EBR Consultant

Job location: Andover, MA

Job Duration: Fulltime/Contract





Mandatory skills:




Sound experience and knowledge working on Rockwell MES FTPC (Factory Talk Pharma Suite) for Modelling Manufacturing Processes in Pharmaceutical industry.
Ability to understand Master Batch Records and create design/functional specifications for MES system
Experience working on creating / revising Electronic Batch Record (EBR) based on product version or process changes
Pharmaceutical Manufacturing exposure
Knowledge of Manufacturing IT systems, IT standards like S88 batch model, ISA 95, GAMP 5.0, 21 CFR Part 11, etc




Preferred Skills:




Knowledge of Manufacturing Execution Systems (preferably, PMX/FTPC/FTPS from Rockwell) and Control Systems
Site MES deployment experience
Biotech process knowledge




Job Role:




Understand batch records and deliver a standard recipe in MES (AMPS) solution leveraging operation building blocks
Train and mentor site recipe authors on MES (AMPS) EBR recipe life cycle (including analysis, authoring, testing, validation, documentation and support)
Support site during go-live transition and post implementation
Site specific requirement analysis and functional specification development (if required)
Interaction with client SMEs to discuss and understand these processes
Preparing “To-Be” and “As-Is” process flows from deployment/ landscape perspective
Identify AMPS Operation building blocks to author Master Recipes
Author and configure MES (AMPS) master recipe
Test, validate and demonstrate master recipes
Assistance with system SOPs
Participate in IQ (if req, OQ and PQ
Impart end user training on new recipes and post go live support 13
Mentor site Master Recipe authors through EBR recipe life cycle
Liaise with technical team on complex problems to provide resolution




Thanks & Regards,

Pavan Singh

Sr. Technical Recruiter

Tel

email :
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