AT01-032426 Cleaning Validation Specialist

Validation & Engineering GroupGreenville, SC
18hOnsite

About The Position

Validation & Engineering Group, Inc. (V&EG) a Pinnaql company is a leading services supplier who provides solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in the following areas: Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services. We are seeking a Cleaning Validation Specialist who will support full lifecycle cleaning validation activities within a regulated manufacturing environment in Greenville, SC. This role is part of a broader initiative to strengthen cleaning validation practices and ensure compliance with current regulatory and internal standards. The position requires both technical ownership and hands-on execution, including strategy development, protocol generation, and coordination of sampling activities. The ideal candidate will be able to independently lead cleaning validation efforts while also supporting execution activities in alignment with production schedules.

Requirements

  • 5+ years of experience in cleaning validation within a regulated environment (pharmaceutical, biotech, or medical device)
  • Proven experience supporting the full lifecycle of cleaning validation (strategy, protocol development, execution, and reporting)
  • Hands-on experience with swab and rinse sampling techniques
  • Strong understanding of GMP requirements and validation principles
  • Ability to work independently
  • Excellent technical writing skills
  • Must be comfortable working on-site in a manufacturing environment
  • Flexibility to support sampling activities based on production schedules, including early, late, or off-shift work as needed
  • Strong coordination skills to work effectively with cross-functional teams
  • Ability and willingness to work in confined spaces, including entering tanks or similar equipment to perform inspections, measurements, and/or sampling activities (in compliance with site safety procedures)

Responsibilities

  • Develop and support cleaning validation strategies and validation plans
  • Author cleaning validation protocols and reports
  • Execute cleaning validation protocols, including swab and rinse sampling
  • Coordinate sampling activities with production and packaging teams to align with manufacturing schedules
  • Perform hands-on sampling activities as required
  • Support and lead deviation investigations related to cleaning validation activities
  • Train operators and staff on cleaning procedures, cleaning techniques, and protocol execution
  • Provide technical guidance on cleaning processes, including solvent selection and cleaning methods
  • Collaborate with Quality, Manufacturing, and Laboratory teams to ensure successful execution of validation activities
  • Primary focus on cleaning validation activities, with flexibility to support other Commissioning, Qualification, and Validation activities as needed based on project demands
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