Cleaning Validation Consultant
Job in
High Point, Guilford County, North Carolina, 27264, USA
Listed on 2026-07-20
Listing for:
S4 Analytics LLC
Full Time
position Listed on 2026-07-20
Job specializations:
-
Quality Assurance - QA/QC
Quality Engineering, Regulatory Compliance Specialist
Job Description & How to Apply Below
We are seeking an experienced Cleaning Validation Consultant to support a large biologics manufacturing expansion. The ideal candidate will lead cleaning validation activities, ensure compliance with cGMP regulations, and support inspection readiness across manufacturing operations.
Key Responsibilities- Author, execute, and review Cleaning Validation protocols (IQ/OQ/PQ)
- Develop MACO/PDE-based residue limits and risk assessments
- Support swab and rinse sampling activities
- Investigate deviations and implement CAPAs
- Maintain Cleaning Validation Master Plan
- Support tech transfer, new product introductions, and regulatory inspections
- Collaborate with Quality, Manufacturing, and Analytical teams
- 6–10+ years of Cleaning Validation experience in Pharma, Biotech, or CDMO
- Strong knowledge of MACO, PDE, FDA, EMA, PIC/S, and cGMP guidelines
- Experience authoring and executing Cleaning Validation protocols
- Hands‑on experience with swab/rinse recovery studies and analytical data review
- Bachelor's degree in a scientific or engineering discipline
- Experience in biologics manufacturing (mAbs, Cell & Gene Therapy)
- Facility expansion or start‑up project experience
- FDA inspection and audit support
- Experience with shared equipment and multi‑product manufacturing environments
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