The following requirement is open with our client.

Title : Serialization/Validation Engineer

Location : Indianapolis, IN

Duration : 12 Months

Relevant Experience (in Yrs.) : 5

Detailed Job Description:

• Experience and in-depth understanding of all system lifecycle deliverables from Commissioning & Qualification (C&Q) and Computer System Validation (CSV) documents through System Retirement. This includes deliverables such as Planning (Project Validation Plan or Validation Master Plan), User/Functional Requirements, Design Specifications, Design Qualification (DQ), Commissioning (FAT, SAT, Startup), Qualification Test Protocols (IQ/OQ/PQ), Process Validation (PV).?Experience of Process Automation Systems?Experience of Computer IT systems?Excellent computer and problem solving skills?Familiarity with pharma packaging processes and packaging equipment custom software?Strong problem-solving and strong analytical skills are essential. Ability to troubleshoot issues and provide timely resolution.?Excellent analytical, organizational, team and project management skills?Understanding of Pharma Serialization.?Understanding of Packaging line hardware, PLC programming.?Experience of vision inspection systems used in packaging.?Familiarity with formal Change Management and Incident Management Processes.?Familiarity with Packaging solutions like Systech, and SAP ATTP and or TraceLink

Must Have:

• Commissioning & Qualification
• Computer System Validation
• Design Qualification