CSV Specialist
Mirus Consulting Group, Bradenton, FL, United States
mîrus Consulting Group is a Puerto Rico based technical services firm headquartered in Humacao. The company specializes in Computer System Validation (CSV) and Information Technology consulting for the pharmaceutical and life sciences industries across Puerto Rico and parts of the United States. Its services include the assessment and validation of automation systems, network infrastructures, and business processes, as well as comprehensive project management support to ensure compliance, efficiency, and operational excellence.
Position Summary The
CSV Specialist
will support the validation lifecycle of computerized and automated systems associated with the PSA Syringe Filling Machine Control System upgrade. This role focuses on Computer System Validation (CSV) activities while working closely with Automation, Engineering, Manufacturing, and Quality to ensure the validated state of upgraded systems including robotics, motion control, PLCs, HMIs, servo systems, VFDs, I/O, and safety components. The project involves replacing obsolete components—including the Adept robot, motion systems, drives, and legacy Windows XP‑based HMI—with modern, validated hardware and software platforms. The CSV Specialist will ensure compliance with GMP, 21 CFR Part 11, EU Annex 11, data integrity principles (ALCOA+), and site SOPs including IM‑S‑230 for computerized system lifecycle management.
Key Responsibilities Computer System Validation
Develop, review, and execute CSV deliverables for the upgraded robot, PLC, motion control, HMI, VFDs, and related computerized systems.
Author and maintain:
System Requirements / URS / FRS
Risk Assessments (including Data Integrity Risk Assessments)
Traceability Matrices
IQ/OQ/PQ protocols and execution evidence
Validation Summary Reports
Ensure compliance with GAMP 5, 21 CFR Part 11, EU Annex 11, and site procedures.
Validate new Windows OS‑based HMI, software applications, and system interfaces.
Support validation of safety functions including Safe‑Cell routines, door contacts, and light curtain logic.
Commissioning & Qualification Collaboration
Support alignment with C&Q activities for:
Commissioning
Installation Qualification (IQ)
Operational Qualification (OQ)
PSA Robot & Motion Control C&Q
PSA Isolator C&Q
Deviations, test witnessing, and approval workflows
Documentation & Lifecycle Management
Responsible for document control for all validation/C&Q documentation:
Load, store, and maintain documents in SharePoint and ALM tools
Route documents for review/approval
Revise documents to address comments and ensure compliance
Maintain documentation structure and quality throughout the project lifecycle
Support updates to SOPs and forms required by the upgrade
Change Control, Testing & Compliance
Perform CSV impact assessments for software, firmware, OS updates, robot programming, PLC logic, and automation configurations.
Support deviations, CAPAs, version control, and backup/restore verification.
Ensure audit‑ready test evidence aligned with ALCOA+ principles.
Participate in project meetings, design reviews, and technical discussions.
Minimum Requirements
BS or higher in Engineering, Computer Science, Chemistry, or related discipline.
Experience working in pharmaceutical manufacturing.
Demonstrated experience in Computer System Validation in GMP‑regulated environments.
Experience with Commissioning & Qualification operations.
Familiarity with Change Control processes.
Strong knowledge of cGMP and regulatory validation requirements.
Proficient documentation skills in English; strong MS Office capability.
Experience with ALM platforms for protocol execution and document control.
Bilingual (English/Spanish).
This Company is an equal employment opportunity employer. We adhere to a policy of making employment decisions without regard to race, color, religion, sex, sexual orientation, national origin, citizenship, age or disability. We assure you that your opportunity for employment with this Company depends solely on your qualifications.
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Position Summary The
CSV Specialist
will support the validation lifecycle of computerized and automated systems associated with the PSA Syringe Filling Machine Control System upgrade. This role focuses on Computer System Validation (CSV) activities while working closely with Automation, Engineering, Manufacturing, and Quality to ensure the validated state of upgraded systems including robotics, motion control, PLCs, HMIs, servo systems, VFDs, I/O, and safety components. The project involves replacing obsolete components—including the Adept robot, motion systems, drives, and legacy Windows XP‑based HMI—with modern, validated hardware and software platforms. The CSV Specialist will ensure compliance with GMP, 21 CFR Part 11, EU Annex 11, data integrity principles (ALCOA+), and site SOPs including IM‑S‑230 for computerized system lifecycle management.
Key Responsibilities Computer System Validation
Develop, review, and execute CSV deliverables for the upgraded robot, PLC, motion control, HMI, VFDs, and related computerized systems.
Author and maintain:
System Requirements / URS / FRS
Risk Assessments (including Data Integrity Risk Assessments)
Traceability Matrices
IQ/OQ/PQ protocols and execution evidence
Validation Summary Reports
Ensure compliance with GAMP 5, 21 CFR Part 11, EU Annex 11, and site procedures.
Validate new Windows OS‑based HMI, software applications, and system interfaces.
Support validation of safety functions including Safe‑Cell routines, door contacts, and light curtain logic.
Commissioning & Qualification Collaboration
Support alignment with C&Q activities for:
Commissioning
Installation Qualification (IQ)
Operational Qualification (OQ)
PSA Robot & Motion Control C&Q
PSA Isolator C&Q
Deviations, test witnessing, and approval workflows
Documentation & Lifecycle Management
Responsible for document control for all validation/C&Q documentation:
Load, store, and maintain documents in SharePoint and ALM tools
Route documents for review/approval
Revise documents to address comments and ensure compliance
Maintain documentation structure and quality throughout the project lifecycle
Support updates to SOPs and forms required by the upgrade
Change Control, Testing & Compliance
Perform CSV impact assessments for software, firmware, OS updates, robot programming, PLC logic, and automation configurations.
Support deviations, CAPAs, version control, and backup/restore verification.
Ensure audit‑ready test evidence aligned with ALCOA+ principles.
Participate in project meetings, design reviews, and technical discussions.
Minimum Requirements
BS or higher in Engineering, Computer Science, Chemistry, or related discipline.
Experience working in pharmaceutical manufacturing.
Demonstrated experience in Computer System Validation in GMP‑regulated environments.
Experience with Commissioning & Qualification operations.
Familiarity with Change Control processes.
Strong knowledge of cGMP and regulatory validation requirements.
Proficient documentation skills in English; strong MS Office capability.
Experience with ALM platforms for protocol execution and document control.
Bilingual (English/Spanish).
This Company is an equal employment opportunity employer. We adhere to a policy of making employment decisions without regard to race, color, religion, sex, sexual orientation, national origin, citizenship, age or disability. We assure you that your opportunity for employment with this Company depends solely on your qualifications.
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