Job Title: Senior Computer System Validation (CSV) Consultant - Concord, NC (Onsite)
Location: Concord, NC (Onsite)
Duration: 12 Months
Visa: Open to All Work Authorisations
Experience: 4–6 Years (Strong Communication Skills Required)
Industry: Pharmaceutical / Life Sciences / Healthcare
Job Summary
We are seeking an experienced Senior Computer System Validation (CSV) Consultant to support validation and compliance initiatives for MES and other GMP-regulated systems within a pharmaceutical/life sciences environment. The ideal candidate will possess strong expertise in Computer System Validation (CSV), IT Governance, Regulatory Compliance, and Quality Systems, with hands-on experience validating manufacturing and enterprise applications in regulated environments.
The consultant will collaborate closely with Quality, Manufacturing, IT, Compliance, and Business stakeholders to ensure systems remain compliant with FDA regulations, GAMP5 guidelines, 21 CFR Part 11 requirements, and internal quality standards throughout the system lifecycle.
Key Responsibilities
- Lead end-to-end Computer System Validation (CSV) activities for MES and other GMP-regulated systems.
- Support validation and compliance efforts for systems and platforms including:
- Manufacturing Execution Systems (MES)
- SAP EWM (Extended Warehouse Management)
- Tulip
- Other GMP/GxP-regulated applications and manufacturing systems
- Prepare, review, and execute validation documentation, including:
- Validation Plans (VP)
- User Requirement Specifications (URS)
- Functional & Design Specifications (FS/DS)
- Risk Assessments
- IQ/OQ/PQ Protocols
- Traceability Matrix
- Validation Summary Reports (VSR)
- SOPs and Work Instructions
- Ensure compliance with:
- FDA 21 CFR Part 11
- GAMP5 Guidelines
- GxP Requirements
- Data Integrity Standards
- IT Governance and Compliance Policies
- Execute and document validation testing activities with appropriate evidence and traceability.
- Collaborate with QA, Manufacturing, IT, Infrastructure, Automation, and third-party vendors during implementation and validation phases.
- Participate in:
- Change Control
- Deviation Management
- CAPA Activities
- Periodic Reviews
- Audit and Inspection Readiness
- Support risk-based validation methodologies and system lifecycle management.
- Ensure systems are maintained in a validated and compliant state.
Required Skills & Experience
- 4–6 years of experience in Computer System Validation (CSV) within pharmaceutical, biotechnology, medical device, or regulated healthcare environments.
- Strong experience validating MES and manufacturing systems.
- Solid understanding of:
- GAMP5
- FDA 21 CFR Part 11
- GxP Compliance
- Data Integrity Principles
- SDLC and Validation Methodologies
- IT Governance and Compliance Frameworks
- Experience authoring and executing CSV documentation and validation protocols.
- Strong knowledge of:
- Audit Readiness
- Change Management
- Deviations
- CAPA Processes
- Excellent communication, documentation, and stakeholder management skills.
- Ability to work effectively with cross-functional and global teams.
Preferred Qualifications
- Experience with Cloud/SaaS Validation in regulated environments.
- Familiarity with Agile and Risk-Based Validation methodologies.
- Exposure to manufacturing automation, digital transformation, and Industry 4.0 initiatives within life sciences.
- Bachelor’s degree in Computer Science, Engineering, Life Sciences, or a related field.
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