Cleaning Validation Specialist Pharma Manufacturing

Job Title: Cleaning Validation Engineer

Location: North Carolina

Duration: 12 Months

Overview:

We’re looking for a Cleaning Validation Engineer with experience in drug product manufacturing—especially with parts washers, autoclaves, and using Kneat software. The role focuses on creating and executing cleaning validation (CV) strategies to ensure our facility in North Carolina meets regulatory standards.

Key Responsibilities:

Develop and manage the site’s Cleaning Validation (CV) strategy and documentation.

Lead cross-functional CV discussions with Operations, QA, QC, Process Support, and Supply Chain.

Coordinate with contractors and readiness teams for cycle development and hold times.

Act as CV Subject Matter Expert (SME) during audits and FDA inspections.

Write and review cleaning procedures; maintain the Cleaning Validation Master Plan.

Adapt SOPs from a European sister site to fit local needs.

Clarify roles and responsibilities for CV activities.

Support CV communication strategies across the site.

Help Project Managers track CV progress.

Ensure all CV efforts meet regulatory standards and are audit-ready.

Identify and track necessary SOPs and deadlines.

Partner with QC and Supply Chain on sampling and materials planning.

Help develop training for staff involved in CV activities.

Support implementation of CV strategies across departments.

Prepare and manage documentation using Kneat.

Localize global CV documents to match site-specific requirements.

Investigate and document any issues during cleaning validation.

Qualifications:

Experience in a CDMO or drug product manufacturing setting.

Proficient in Kneat software.

Deep understanding of cleaning validation, including autoclaves and parts washers.

Strong collaboration and communication skills.

Experience acting as SME in audits or inspections.