Company:
Diverse Lynx
Location: Raritan
Closing Date: 15/10/2024
Hours: Full Time
Type: Permanent
Job Requirements / Description
Expertise in high-performance, cross-functional teams developing, and supporting information systems in the Medical Device and pharmaceutical manufacturing industries
Understand the paper Batch record and business process flow in collaboration with business SMEs
Data-driven, user-centric, technology, and information solutions business systems analyst with a deep understanding of business processes under GxP, ISO, and regulatory compliance
Knowledge of Mfg. Process Controls and Reporting program
Awareness of Electronic Lot History Records using Camstar Software for Medical Device/ Pharma industries
Implement and execute the shopfloor transaction using OpCenter Execution Discrete in Discrete manufacturing Industry
Experienced in Camstar (V8.x) Modeling Configuration, Designer,OpCenter Connect MOM, OpCenter Connect cloud, Portal studio
Experience in C# and object oriented programming concepts
Author Computer System Validation (CSV) documents such as Functional Risk Assessment, Validation Plan, System Test Plan, Test Summary Reports (IQ/OQ/UAT), Validation Report, etc. following industry standard GAMS 5 and/or following the client Quality standards. Author and review test scripts (IQ, OQ, PQ)
Perform IQ (application and devices), OQ (including the Siemens CAMSTAR / OpCenter MES System integration with SAP, Client and other L3/L2 systems)
Assist Recipe Author / Modeler in Key user and end user training content creation based on the standard Siemens CAMSTAR / OpCenter MES System product training material
Assist CoE and Site in conducting End user training
Diverse Lynx LLC is an Equal Employment Opportunity employer. All qualified applicants will receive due consideration for employment without any discrimination. All applicants will be evaluated solely on the basis of their ability, competence and their proven capability to perform the functions outlined in the corresponding role. We promote and support a diverse workforce across all levels in the company.
Understand the paper Batch record and business process flow in collaboration with business SMEs
Data-driven, user-centric, technology, and information solutions business systems analyst with a deep understanding of business processes under GxP, ISO, and regulatory compliance
Knowledge of Mfg. Process Controls and Reporting program
Awareness of Electronic Lot History Records using Camstar Software for Medical Device/ Pharma industries
Implement and execute the shopfloor transaction using OpCenter Execution Discrete in Discrete manufacturing Industry
Experienced in Camstar (V8.x) Modeling Configuration, Designer,OpCenter Connect MOM, OpCenter Connect cloud, Portal studio
Experience in C# and object oriented programming concepts
Author Computer System Validation (CSV) documents such as Functional Risk Assessment, Validation Plan, System Test Plan, Test Summary Reports (IQ/OQ/UAT), Validation Report, etc. following industry standard GAMS 5 and/or following the client Quality standards. Author and review test scripts (IQ, OQ, PQ)
Perform IQ (application and devices), OQ (including the Siemens CAMSTAR / OpCenter MES System integration with SAP, Client and other L3/L2 systems)
Assist Recipe Author / Modeler in Key user and end user training content creation based on the standard Siemens CAMSTAR / OpCenter MES System product training material
Assist CoE and Site in conducting End user training
Diverse Lynx LLC is an Equal Employment Opportunity employer. All qualified applicants will receive due consideration for employment without any discrimination. All applicants will be evaluated solely on the basis of their ability, competence and their proven capability to perform the functions outlined in the corresponding role. We promote and support a diverse workforce across all levels in the company.
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