Senior CSV Engineer - IT/OT Infrastructure - Philadelphia :
Job Title:
Senior CSV Consultant with IT/OT Infrastructure Validation Expertise
Location:
Philadelphia
Employment Type:
C2C
Industry:
Biologics
Start:
January
Job Description
We are seeking a highly skilled and experienced
Senior CSV Consultant
with a strong background in IT/OT infrastructure validation. This role is crucial to ensuring that our clients' systems comply with regulatory requirements, such as FDA 21 CFR Part 11, Annex 11, and GxP guidelines. The ideal candidate will act as a subject matter expert, leading validation projects and collaborating with cross-functional teams to drive successful outcomes.
Key Responsibilities
Validation Expertise:
Lead CSV efforts for IT/OT infrastructure projects, including network systems, servers, virtualization platforms, and cloud solutions.
Author and review validation deliverables (URS, FRS, RTM, IQ, OQ, PQ, VSR).
Ensure compliance with regulatory requirements and industry best practices.
Project Management:
Plan and execute validation activities, ensuring timelines and quality standards are met.
Coordinate with cross-functional teams, including QA, IT, and engineering, to align on project objectives.
Risk Management:
Perform risk assessments to identify critical control points in IT/OT infrastructure systems.
Develop and implement mitigation strategies to ensure system integrity and compliance.
Qualifications and Experience
Required:
Bachelor's degree in Engineering, Computer Science, Life Sciences, or related field.
Minimum of 12+ years of experience in CSV, with a focus on IT/OT infrastructure validation.
In-depth knowledge of regulatory frameworks (FDA, EMA, GxP, 21 CFR Part 11, Annex 11).
Hands-on experience with validation of systems such as SCADA, PLC, MES, and ERP platforms.
Familiarity with virtualization tools (VMware, Hyper-V), cloud services, and data integrity principles.
Preferred:
Certifications such as PMP, CSQE, or ITIL.
Experience in life sciences, biotech, or pharmaceutical environments.
Knowledge of emerging technologies, such as IoT and AI, and their validation requirements.
Best Regards
Piyush
Technical Recruiter
Stellent
IT
Email:
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Dice Id:
91022079
Position Id:
2024-37604