Cleaning Validation Consultant

i-Pharm GxP; Illinois; On-site; USD 90,000 - 130,000; Full time

Job summary

i-Pharm GxP is seeking a Cleaning Validation Consultant for a 12-month onsite engagement at a major GMP pharmaceutical site. The role requires hands-on experience in cleaning validation from protocol development through reporting, with a focus on data integrity.

The successful candidate will author and review validation documents, manage lifecycle activities, perform sampling and data analysis, and ensure audit readiness using Kneat. Independent work with minimal ramp-up is expected.

Qualifications

• 5–7 years of hands-on cleaning validation experience in pharma/biotech.
• Kneat validation lifecycle experience is mandatory.
• Ability to work independently from day one.
• Strong GMP/GDP knowledge and QA documentation practices.

Responsibilities

• Lead and execute cleaning validation activities site-wide.
• Author, review, and approve cleaning validation protocols and reports.
• Manage validation lifecycle per GMP and regulatory expectations.
• Collaborate with validation, quality, manufacturing, and engineering teams.
• Maintain Kneat records ensuring audit readiness.

Skills

Cleaning validation

Kneat experience

Independent work

GMP/GDP knowledge

Documentation practices

Tools

Kneat

Job description

Job Title: Cleaning Validation Consultant

Contract: 12-Month | Onsite | W2 | Competitive Rate

On-site: 5 days a week - 100% Onsite

We are supporting a major GMP pharmaceutical manufacturer at an established, legacy site and are seeking an experienced Cleaning Validation Consultant to own and execute cleaning validation activities. This is a hands-on role for someone who can hit the ground running from day one.

Key Responsibilities

• Lead and execute cleaning validation activities across the site, from protocol development through execution and reporting.
• Author, review, and approve cleaning validation protocols, reports, and supporting documentation.
• Manage cleaning validation lifecycle activities in line with GMP and regulatory expectations.
• Perform sampling, data analysis, and assessment against established acceptance criteria.
• Support the maintenance and remediation of cleaning validation documentation on an older, established site.
• Author and maintain validation records within Kneat, ensuring data integrity and audit-readiness.
• Drive collaboration across validation, quality, manufacturing, and engineering teams.

Required Experience

• 5–7 years of hands-on cleaning validation experience within pharmaceutical or biotechnology manufacturing.
• Kneat experience required (non-negotiable).
• Proven ability to work independently and deliver from day one with minimal ramp-up.
• Strong knowledge of GMP/GDP requirements and quality documentation practices.
• Solid understanding of cleaning validation lifecycle, sampling methodologies, and acceptance criteria.
• Experience working on established or legacy manufacturing sites (advantageous).

Preferred Technical Experience

• Direct experience with one or more of the following:
• Cleaning validation protocol authoring and execution
• Kneat validation lifecycle management (required)
• Sampling, recovery studies, and MACO/acceptance criteria calculations
• GMP documentation control and audit support