Senior Validation Consultant
i-Pharm GxP, Wilson, NC, United States
Principal Validation Consultant – Sterile / Fill-Finish Manufacturing
Location:
Wilson, North Carolina, USA
Contract Role:
12-Months with extension
W2 ONLY, competitive rate on offer
Overview We are supporting a leading sterile manufacturing facility in Wilson, NC undergoing continued expansion and operational scale-up. This role requires a Principal Validation Consultant to provide technical leadership across validation activities, with a strong focus on aseptic processing and fill-finish operations.
This is a senior, hands-on position where you will act as a subject matter expert, driving validation strategy while supporting execution across critical GMP systems.
Key Responsibilities
Provide technical leadership across validation lifecycle activities (process, equipment, cleaning, and utilities)
Lead validation strategy development aligned with regulatory expectations and site procedures
Author, review, and approve validation deliverables including protocols and summary reports (IQ/OQ/PQ, PPQ)
Act as SME for aseptic processing, supporting media fills, sterilization validation, and contamination control strategy
Support commissioning and qualification activities in collaboration with CQV and engineering teams
Drive risk-based validation approaches and ensure alignment with current industry best practices
Lead and support deviation investigations, CAPAs, and change control related to validation activities
Interface with Quality, Manufacturing, and Regulatory teams to ensure inspection readiness
Mentor junior validation engineers and provide oversight on documentation quality and execution
Required Experience & Qualifications
10–15+ years of validation experience within pharmaceutical or biotechnology manufacturing
Strong background in sterile / aseptic fill-finish environments (essential)
Extensive experience with:
Process validation (PPQ)
Aseptic process simulation (media fills)
Deep knowledge of GMP regulations and guidance (FDA, EU Annex 1, ICH)
Proven experience operating at a senior or principal level on complex manufacturing sites
Strong authorship and review capabilities for validation documentation
Ability to operate both strategically and hands-on within fast-paced project environments
Preferred
Experience supporting regulatory inspections or audit responses
Exposure to facility expansions or new product introductions
Familiarity with digital validation systems
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Location:
Wilson, North Carolina, USA
Contract Role:
12-Months with extension
W2 ONLY, competitive rate on offer
Overview We are supporting a leading sterile manufacturing facility in Wilson, NC undergoing continued expansion and operational scale-up. This role requires a Principal Validation Consultant to provide technical leadership across validation activities, with a strong focus on aseptic processing and fill-finish operations.
This is a senior, hands-on position where you will act as a subject matter expert, driving validation strategy while supporting execution across critical GMP systems.
Key Responsibilities
Provide technical leadership across validation lifecycle activities (process, equipment, cleaning, and utilities)
Lead validation strategy development aligned with regulatory expectations and site procedures
Author, review, and approve validation deliverables including protocols and summary reports (IQ/OQ/PQ, PPQ)
Act as SME for aseptic processing, supporting media fills, sterilization validation, and contamination control strategy
Support commissioning and qualification activities in collaboration with CQV and engineering teams
Drive risk-based validation approaches and ensure alignment with current industry best practices
Lead and support deviation investigations, CAPAs, and change control related to validation activities
Interface with Quality, Manufacturing, and Regulatory teams to ensure inspection readiness
Mentor junior validation engineers and provide oversight on documentation quality and execution
Required Experience & Qualifications
10–15+ years of validation experience within pharmaceutical or biotechnology manufacturing
Strong background in sterile / aseptic fill-finish environments (essential)
Extensive experience with:
Process validation (PPQ)
Aseptic process simulation (media fills)
Deep knowledge of GMP regulations and guidance (FDA, EU Annex 1, ICH)
Proven experience operating at a senior or principal level on complex manufacturing sites
Strong authorship and review capabilities for validation documentation
Ability to operate both strategically and hands-on within fast-paced project environments
Preferred
Experience supporting regulatory inspections or audit responses
Exposure to facility expansions or new product introductions
Familiarity with digital validation systems
#J-18808-Ljbffr