MES Opcenter/Camstar Modeler (Remote) at Tanisha Systems

Job Description:

We are seeking a dynamic professional with proven expertise in Siemens Opcenter Medical Devices / Camstar application within the Manufacturing Execution domain. The ideal candidate will have a strong background in developing and supporting information systems in the Medical Device and pharmaceutical manufacturing industries.

Key Responsibilities:

• Collaborate with business SMEs to understand paper Batch records and business process flows.
• Act as a data-driven, user-centric business systems analyst with a deep understanding of business processes under GxP, ISO, and regulatory compliance.
• Implement and execute shopfloor transactions using OpCenter Execution Discrete in the Discrete manufacturing industry.
• Utilize knowledge of Manufacturing Process Controls and Reporting programs.
• Maintain awareness of Electronic Lot History Records using Camstar Software for Medical Device/Pharma industries.
• Configure and design Camstar (V8.x) Modeling, OpCenter Connect MOM, OpCenter Connect Cloud, and Portal Studio.
• Develop and review Computer System Validation (CSV) documents such as Functional Risk Assessments, Validation Plans, System Test Plans, Test Summary Reports (IQ/OQ/UAT), and Validation Reports following industry standards (GAMS 5) and client Quality standards.
• Author and review test scripts (IQ, OQ, PQ).
• Perform IQ (application and devices) and OQ, including the integration of Siemens CAMSTAR / OpCenter MES System with SAP, PAC, and other L3/L2 systems.
• Assist Recipe Authors/Modelers in creating Key user and end-user training content based on standard Siemens CAMSTAR / OpCenter MES System product training material.
• Conduct end-user training in collaboration with CoE and Site teams.

Qualifications:

• Proven expertise in Siemens Opcenter Medical Devices / Camstar application.
• Experience in high-performance, cross-functional teams.
• Strong understanding of GxP, ISO, and regulatory compliance.
• Proficiency in C# and object-oriented programming concepts.
• Experience with Camstar (V8.x) Modeling Configuration, Designer, OpCenter Connect MOM, OpCenter Connect Cloud, and Portal Studio.

Preferred Skills:

• Excellent communication and collaboration skills.
• Strong analytical and problem-solving abilities.
• Ability to work independently in a remote setting.