Cleaning validation - Kasmo Global : Job Details

Cleaning validation

Kasmo Global

Job Location : Wilmington,NC, USA

Posted on : 2025-08-05T07:33:46Z

Job Description :

Global Compliance Partners was founded by a team experts with experience in the Biotech, Life Science and Medical Device Industry. GCP prides itself in technical excellence, responsible stewardship and quality of service. We distinguish ourselves from our peers with our ability to build efficiencies in business and technical problem solving. Our team thoroughly understands the compliance and validation needs of clients and implements lean risk based approaches towards all projects. Roles & Responsibilities:

  • Lead generation of all Cleaning Validation Documentation - Master plans, Protocols, Reports.
  • Develop and execute cleaning validation protocols (IQ/OQ/PQ) for manufacturing equipment, CIP/SIP systems, and utilities.
  • Conduct risk assessments and gap analyses on cleaning procedures and historical data to ensure compliance with regulatory requirements (FDA, EMA, WHO).
  • Establish and implement cleaning verification and validation strategies, including hold time studies, swab/rinse sampling, recovery studies, and worst-case product matrix identification.
  • Perform residue limit calculations (MACO calculations using PDE, therapeutic dose, and toxicological data).
  • Lead cleaning validation lifecycle management including revalidation criteria and continuous improvement initiatives.
  • Collaborate with QA, Manufacturing, QC, and Engineering to coordinate validation activities with minimal disruption to production.
  • Review and approve cleaning SOPs, batch records, validation protocols, and reports.
  • Investigate deviations or failures in cleaning validation and author associated CAPAs.
Experience:
  • SME in Cleaning Validation, minimum 3-5 years
  • Working knowledge of ASTM E2500 / Leveraging Verification process
  • Experience with liaising with other departments and building PMs/leads
  • Prior experience with cGMP or in other highly regulated industries such as on Large Scale Projects and/or GMP operational facility.
  • Experience with liaising with other departments and engineers/QA, ensuring streamlined implementation of documentation review process or similar type process.
  • Willingness to step in a proactive manner for driving progress.
  • Strong communication skills and ability to escalate issues as needed.
  • BA/BS in a related field and 3+ years' experience successfully executing complex projects in a Pharma/cGMP environment.
  • Emphasis for this hire is on attitude (Positive Can-Do attitude) and strong collaboration.
  • Acts with detail-driven ownership and follow through.
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