Validation Engineer II CSV and Compliance Support

Hillsboro, IL - USA

Monthly Salary: Not Disclosed

Posted on: 4 days ago

Vacancies: 1 Vacancy

Job Summary

Validation Engineer II - CSV and Compliance Support

Location: Hillsboro OR (onsite)
Duration: 1 year extendable

Responsibilities:

Work to support the ITOT System owners in tasks associated with the lifecycle of computer system ie. maintenance validation documentation testing.
Create/update Computer System validation and lifecycle support documentation as the need arises for ITOT computer systems (DeltaV PI MES SCADA LyoPLus FIT BAS WAGIT). Systems will fall between Level 2 and 3 of the ISA-95 model.
Help perform MILE (annual system maintenance) activities for ITOT Systems. For example create update execute or review installation protocols test protocols etc.
Own Quality Management System records (CAPA Planned Events Deviations) and orchestrate completion of activities needed.
Perform system periodic reviews- This entails performing data collection from the deviations database on the past 3 years worth of planned and unplanned events review impact on systems validated state and draft reports.
Support System Owner squad in the overall procurement development integration modification operation maintenance and retirement of ITOT systems.
Support validation activities generation approval and execution of validation protocols
Assist System Owners in system maintenance activities such as Periodic System Audit Trail Review account audits etc.
Creating reports for various systems on demand
Work with the System Owners and Business Process Owners for the upgrade/patching and changes to the system to ensure GMP compliance.
Support on documents management systems (Veeva Condor eVal Roche)
Support the team with administrative tasks such as document formatting document routing.
Collaborate with local and global stakeholders in defining and completing validation and compliance activities.
Attend Quality Huddle Meetings
Provide Quality Metrics
Align with global Validation protocols and policies

MUST-HAVE Qualifications/ Requirements:

Bachelor of Science or equivalent in computer science engineering life sciences or related field.
Minimum 5 years experience in Computer systems Validation frameworks (CSV/CSA GAMP) preferably in the Pharma industry.
Knowledge of or experience with the following technical areas is preferred: SCADA OSI-PI Siemens Desigo Rockwell Factory Talk Pharmasuite DeltaV Manufacturing Execution Systems (MES) Systems administration and EBR recipe authoring software development
Good understanding of the ISA-95 model. Experience working with Level 2 and Level 3 systems is required. Experience working with Level 1 systems is a plus.
Knowledge of Food and Drug Administration regulations/guidance (i.e. CFR 21 FDA Part 11 Annex 11 EU GMP Annex 1 GxP practices) and Data Integrity principles.
Good understanding of system and data integrity risk assessment concepts.

Validation Engineer II - CSV and Compliance Support Location: Hillsboro OR (onsite) Duration: 1 year extendable Responsibilities: Work to support the ITOT System owners in tasks associated with the lifecycle of computer system ie. maintenance validation documentation testing. Create/update Compute...

Validation Engineer II - CSV and Compliance Support

Location: Hillsboro OR (onsite)
Duration: 1 year extendable

Responsibilities:

Work to support the ITOT System owners in tasks associated with the lifecycle of computer system ie. maintenance validation documentation testing.
Create/update Computer System validation and lifecycle support documentation as the need arises for ITOT computer systems (DeltaV PI MES SCADA LyoPLus FIT BAS WAGIT). Systems will fall between Level 2 and 3 of the ISA-95 model.
Help perform MILE (annual system maintenance) activities for ITOT Systems. For example create update execute or review installation protocols test protocols etc.
Own Quality Management System records (CAPA Planned Events Deviations) and orchestrate completion of activities needed.
Perform system periodic reviews- This entails performing data collection from the deviations database on the past 3 years worth of planned and unplanned events review impact on systems validated state and draft reports.
Support System Owner squad in the overall procurement development integration modification operation maintenance and retirement of ITOT systems.
Support validation activities generation approval and execution of validation protocols
Assist System Owners in system maintenance activities such as Periodic System Audit Trail Review account audits etc.
Creating reports for various systems on demand
Work with the System Owners and Business Process Owners for the upgrade/patching and changes to the system to ensure GMP compliance.
Support on documents management systems (Veeva Condor eVal Roche)
Support the team with administrative tasks such as document formatting document routing.
Collaborate with local and global stakeholders in defining and completing validation and compliance activities.
Attend Quality Huddle Meetings
Provide Quality Metrics
Align with global Validation protocols and policies

MUST-HAVE Qualifications/ Requirements:

Bachelor of Science or equivalent in computer science engineering life sciences or related field.
Minimum 5 years experience in Computer systems Validation frameworks (CSV/CSA GAMP) preferably in the Pharma industry.
Knowledge of or experience with the following technical areas is preferred: SCADA OSI-PI Siemens Desigo Rockwell Factory Talk Pharmasuite DeltaV Manufacturing Execution Systems (MES) Systems administration and EBR recipe authoring software development
Good understanding of the ISA-95 model. Experience working with Level 2 and Level 3 systems is required. Experience working with Level 1 systems is a plus.
Knowledge of Food and Drug Administration regulations/guidance (i.e. CFR 21 FDA Part 11 Annex 11 EU GMP Annex 1 GxP practices) and Data Integrity principles.
Good understanding of system and data integrity risk assessment concepts.