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EBR Consultant
Ref No.: 18-71552
Location: Andover, Massachusetts
Position Type:Full Time/Contract
Start Date: 09/27/2018
Job Title: EBR Consultant
Job Location: Andover, MA

Mandatory skills:
1. Sound experience and knowledge working on Rockwell MES FTPC (Factory Talk Pharma Suite)
for Modelling Manufacturing Processes in Pharmaceutical industry.
2. Ability to understand Master Batch Records and create design/functional specifications for
MES system
3. Experience working on creating / revising Electronic Batch Record (EBR) based on product version or process changes
4. Pharmaceutical Manufacturing exposure
5. Knolwedge 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:
1. Understand batch records and deliver a standard recipes in MES (AMPS) solution leveraging operation building blocks
2. Train and mentor site recipe authors on MES (AMPS) EBR recipe life cycle (including analysis, authoring, testing, validation, documentation and support)
3. Support site during go-live transition and post implementation
4. Site specific requirement analysis and functional specification development (if required)
5. nteraction with client SMEs to discuss and understand these processes
6. Preparing "To-Be” and "As-Is” process flows from deployment/ landscape perspective
7. Identify AMPS Operation building blocks to author Master Recipes
8. Author and configure MES (AMPS) master recipe
9. Test, validate and demonstrate master recipes
10. Assistance with system SOPs
11. Participate in IQ (if req.), OQ and PQ
12. Impart end user training on new recipes and post go live support 13
13. Mentor site Master Recipe authors through EBR recipe life cycle
14. Liaise with technical team on complex problems to provide resolution