Staftonic LLC

Cleaning Validation Engineer Job at Staftonic LLC in Cary

Staftonic LLC, Cary, NC, United States, 27518

Title: Cleaning Validation Engineer

Location: Cary, North Carolina

Employment type: Long Term Contract

Develop, execute, and review cleaning validation protocols, reports, and supporting documentation.
Validate cleaning procedures for manufacturing equipment, vessels, skids, and pipelines.
Perform swab and rinse sampling, and analyze results against acceptance criteria.
Establish worst-case product matrix and determine cleaning limits using MACO/Carryover calculations.
Prepare, implement, and maintain the Cleaning Validation Master Plan (CVMP).
Conduct risk assessments, investigate deviations, and manage CAPA related to cleaning validation.
Ensure compliance with cGMP, FDA, EMA, MHRA, and PIC/S regulatory requirements.
Collaborate with Production, QA, and Engineering teams, including during audits and inspections.
Perform periodic revalidation of cleaning procedures, CIP/SIP cycles, and utility systems.

Bachelor’s or Master’s degree in Pharmacy, Chemical Engineering, Biotechnology, or related field.
6+ years of hands-on experience in Cleaning Validation within pharmaceutical or biopharmaceutical environments.
In-depth knowledge of cleaning validation guidelines and global regulatory expectations.
Proficiency in analytical techniques such as HPLC and TOC for residue testing.
Strong technical documentation, problem-solving, and cross-functional collaboration skills.

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