What are the responsibilities and job description for the Senior Validation Consultant position at i-Pharm GxP?
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)
- Cleaning validation
- Equipment qualification
- 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