LL01-120425 CSV Specialist
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Job Location:
Clayton, OH - USA
Monthly Salary:
Not Disclosed
Posted on:
14 hours ago
Vacancies:
1 Vacancy
Job Summary
Validation & Engineering Group Inc. (V&EG) is a leading services supplier who provides solutions for the Pharmaceutical Biotechnology Chemical Food and Medical Devices industries in the following areas: Laboratory Compliance Computer Engineering Project Management Validation and other services.
We are seeking a talented dedicated individual committed to work under the highest ethics standards for the following position:
Computerized Systems Validation (CSV) Specialist for IT/Automation System Upgrades
Position Summary
The CSV Specialist will support computerized system upgrades and lifecycle validation activities for manufacturing automation MES building management and data historian platforms in a regulated biopharmaceutical environment. The role ensures that all IT/Automation systems remain compliant with cGMP 21 CFR Part 11 GAMP 5 and applicable data integrity requirements throughout design configuration testing and deployment.
This individual will collaborate with IT Automation Quality and Engineering teams to develop validation documentation manage test execution and ensure systems are released for GMP use in a timely and controlled manner.
Key Responsibilities
CSV & Compliance
Plan and execute validation activities for system upgrades patches new deployments and configuration enhancements.
Develop and maintain CSV documentation including:
Validation Plans
Risk Assessments (FMEA/Part 11/Data Integrity)
User Requirements (URS) Functional Specs (FS)
Traceability Matrices
Test Protocols (IQ/OQ/PQ) Data Integrity Assessments
Validation Summary Reports (VSR)
Apply GAMP 5 and data integrity principles (ALCOA) in all validation deliverables.
Ensure compliance with 21 CFR Part 11 and Annex 11 requirements.
Testing & HP ALM Administration
Execute and document qualification testing in HP ALM (required).
Track test progress deviations and defects within ALM workflows.
Partner with Quality to review and close discrepancies and change controls.
Support periodic review and re-validation strategies for CSV-maintained systems.
Technical & System Focus
Work closely with vendors and automation SMEs to understand system changes for:
DeltaV process control system upgrades and configuration changes
Syncade MES recipe workflow and unit procedure modifications
Siemens PCS 7 process automation enhancements
Siemens Desigo CC BMS/BAS upgrades for facilities and cleanrooms
Aveva OSI PI historian infrastructure and data model improvements
Assess GMP impact for new functionality system patches and cybersecurity upgrades.
Support backup/restore testing system hardening and validated state lifecycle maintenance.
Project Support
Participate in project planning FAT/SAT testing and system handovers.
Provide CSV input to change control risk assessments and configuration documentation.
Contribute to schedule updates and progress reports with cross-functional team leads.
Qualifications
Education
Bachelors degree in Engineering IT Computer Science Life Sciences or related field.
Experience
37 years in CSV within regulated (GMP) environments.
Hands-on validation experience with HP ALM.
Experience supporting upgrades or implementations of one or more of the following:
DeltaV Syncade Siemens PCS 7 Siemens Desigo CC OSI PI
Knowledge of:
21 CFR Part 11 Annex 11
GAMP 5
Data Integrity Expectations (ALCOA)
Basic understanding of automation architectures and IT infrastructure
Soft Skills
Strong organizational skills and attention to detail.
Excellent communication and document writing abilities.
Ability to interpret technical information and translate it into compliant documentation.
Comfortable working in a fast-paced project environment with multiple priorities.
Required Experience:
IC
Key Skills
- Sales Experience
- Crane
- Customer Service
- Communication skills
- Heavy Equipment Operation
- Microsoft Word
- Case Management
- OSHA
- Team Management
- Catheterization
- Microsoft Outlook Calendar
- EHS
About Company
Validation & Engineering Group Proudly serving our clients since 1997 Validation & Engineering Group provides world-class service and expertise to the Biotechnology, Food Safety and Quality, Medical Devices, and Pharmaceutical Industries. We offer our clients: Validation, Control Syst ... View more
