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Software Engineer IV

In Arizona / United States

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Software Engineer IV   

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JOB TITLE:

Software Engineer IV

JOB TYPE:

JOB SKILLS:

JOB LOCATION:

South Branchburg NJ Arizona / United States

JOB DESCRIPTION:

The position is hybrid with 3-4 days onsite


1. Assists the business in the use and utilization of Information Systems; MES/ERP/SAP, LIMS, eDocCompliance, TrackWise, SDR-WinDream, Crystal Enterprise or other Compliant Systems used with the RMS Quality System.


2. Participates, Contributes and/or Leads small and large (portfolio) projects. Authors, reviews, and consults on validation documentation including but not limited to Test Scripts, Validation Plans, Installation Qualifications, Operational Qualifications, Performance Qualifications and Validation Reports. Performs system testing and validation. Ensures compliance with corporate and global Roche and Diagnostics standards (e.g., Roche and Diagnostics Core, IT Project Methodology, CSV rules & guidelines).


3. Performs support for the productive applications and ensures compliance to corporate and global Roche and Diagnostics standards.


4. Applies business process functional knowledge to manage the design and improvement of those processes with the objective to improve systems utilization while maintaining compliance with the CFR Part 820, 21 CFR Part 11 as well as ISO-13485 and other GxP related authorities, while improving business efficiencies.


5. Presents new or upgraded system capabilities and drives knowledge to users, creates and deploys training materials for Roche Quality systems.


6. Performs support of production applications by responding to service desk calls, tracking problems/issues, and following up with customers.


7. Investigates business and/or applications problems. Determines root cause(s), develops, and evaluates alternative solutions, and coordinates selection and implementation of solution.


Skills
1. Experience in CSV methodologies is required.


2. Systems experience with Rockwell Pharmasuite is mandatory.

Education
.BS/MS in Computer Science or equivalent experience.


Position Details

POSTED:

Oct 15, 2022

EMPLOYMENT:

INDUSTRY:

SNAPRECRUIT ID:

S1660244406787162

LOCATION:

Arizona / United States

CITY:

South Branchburg NJ

Job Origin:

Jobsrus_organic_feed

A job sourcing event
In Dallas Fort Worth
Aug 19, 2017 9am-6pm
All job seekers welcome!

Software Engineer IV    Apply

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The position is hybrid with 3-4 days onsite


1. Assists the business in the use and utilization of Information Systems; MES/ERP/SAP, LIMS, eDocCompliance, TrackWise, SDR-WinDream, Crystal Enterprise or other Compliant Systems used with the RMS Quality System.


2. Participates, Contributes and/or Leads small and large (portfolio) projects. Authors, reviews, and consults on validation documentation including but not limited to Test Scripts, Validation Plans, Installation Qualifications, Operational Qualifications, Performance Qualifications and Validation Reports. Performs system testing and validation. Ensures compliance with corporate and global Roche and Diagnostics standards (e.g., Roche and Diagnostics Core, IT Project Methodology, CSV rules & guidelines).


3. Performs support for the productive applications and ensures compliance to corporate and global Roche and Diagnostics standards.


4. Applies business process functional knowledge to manage the design and improvement of those processes with the objective to improve systems utilization while maintaining compliance with the CFR Part 820, 21 CFR Part 11 as well as ISO-13485 and other GxP related authorities, while improving business efficiencies.


5. Presents new or upgraded system capabilities and drives knowledge to users, creates and deploys training materials for Roche Quality systems.


6. Performs support of production applications by responding to service desk calls, tracking problems/issues, and following up with customers.


7. Investigates business and/or applications problems. Determines root cause(s), develops, and evaluates alternative solutions, and coordinates selection and implementation of solution.


Skills
1. Experience in CSV methodologies is required.


2. Systems experience with Rockwell Pharmasuite is mandatory.

Education
.BS/MS in Computer Science or equivalent experience.



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