Cleaning Validation Consultant

i-Pharm GxP; North Carolina; Hybrid; USD 110,000 - 150,000; Full time

Job summary

i-Pharm GxP in North Carolina is seeking an experienced Cleaning Validation Consultant to lead cleaning validation activities across multiple manufacturing suites ahead of a major regulatory inspection window. You will author and execute validation protocols and manage residue limits while partnering with Quality and Manufacturing to maintain an inspection-ready site.

The role requires 6–10+ years in cleaning validation in GMP pharma/biotech/CDMO environments, with a data-driven approach to

Qualifications

• 6–10+ years in cleaning validation within GMP pharma/biotech/CDMO.
• Experience authoring and executing validation protocols based on risk and data.
• Knowledge of MACO/PDE-based limit setting and regulatory expectations (FDA/EMA/PIC/S).

Responsibilities

• Author, execute and report cleaning validation protocols for process and equipment cleaning.
• Develop residue limits and acceptance criteria based on toxicology data and risk assessment.
• Partner with Analytical/QC to qualify swab and rinse methods and review recovery data.
• Investigate deviations and develop CAPAs.
• Maintain the cleaning validation master plan and ensure ongoing control.
• Support tech transfer and new product introductions by assessing cleaning impact.
• Liaise with Quality Assurance to ensure documents meet cGMP and inspection readiness.
• Provide SME support during regulatory inspections and client audits.

Skills

Cleaning validation

GMP experience

Data-driven approach

Root cause analysis

Education

Bachelor's degree in Chemistry, Chemical Engineering, or related field

Job description

Contract: 12-month Contract (2-3+ year scope)

Onsite Requirement: Hybrid

Overview

We are supporting a large-scale biologics manufacturing facility undergoing significant capacity expansion in the North Carolina life sciences corridor, and are seeking an experienced Cleaning Validation Consultant to lead cleaning validation activities across multiple manufacturing suites ahead of a major regulatory inspection window.

This role exists to ensure cleaning processes for both single-use and reusable equipment trains are robust, scientifically justified and fully documented as the site scales production. You will author and execute cleaning validation protocols, manage residue and analytical limits, and partner closely with Quality and Manufacturing to keep the site inspection-ready throughout a period of rapid growth.

Key Responsibilities

• Author, execute and report cleaning validation protocols (IQ/OQ/PQ) for process and equipment cleaning across new and existing manufacturing trains
• Develop residue limits and acceptance criteria based on toxicological data, MACO calculations and risk assessment
• Partner with Analytical/QC teams to qualify swab and rinse sampling methods and review analytical recovery data
• Investigate and resolve cleaning validation deviations, including root cause analysis and CAPA development
• Maintain the site cleaning validation master plan and ensure ongoing state of control through periodic verification
• Support tech transfer and new product introduction activities by assessing cleaning impact and updating validation strategy
• Liaise with Quality Assurance to ensure all documentation meets cGMP standards and is inspection-ready
• Provide SME support during regulatory inspections and client audits on cleaning validation matters

Required Experience

• 6–10+ years in cleaning validation within a GMP pharmaceutical, biotech or CDMO environment
• Demonstrable experience authoring and executing cleaning validation protocols from a risk-based, data-driven approach
• Strong working knowledge of MACO/PDE-based limit setting and current regulatory expectations (FDA, EMA, PIC/S)
• Experience qualifying and interpreting swab/rinse recovery and analytical testing data
• Bachelor's degree in Chemistry, Chemical Engineering, Microbiology or related scientific discipline

Preferred Experience

• Experience in large molecule / biologics manufacturing (mAbs, cell or gene therapy)
• Track record supporting cleaning validation through a facility expansion or new suite start-up
• Experience preparing cleaning validation documentation for FDA PAI or pre-approval inspections
• Familiarity with shared-equipment trains and multi-product facility cleaning strategies
• Comfortable operating independently and managing competing protocol timelines in a fast-paced GMP environment