Careers At Validation & Engineering Group

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MV02-021226 Sr Cleaning Validation Specialist

Department: Field - LC
Location: Manati, 091

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 talented, dedicated individual committed to work under the highest ethics standards for the following position:

  • Senior Cleaning Validation Specialist

Summary:

Senior Cleaning Validation Specialist to support cleaning validation lifecycle activities within a regulated cGMP manufacturing environment. This role is critical in ensuring equipment cleaning processes meet regulatory and quality compliance standards.

Key Responsibilities

  • Lead cleaning validation lifecycle activities
  • Develop & review protocols and reports
  • Define sampling strategies and risk assessments
  • Establish acceptance criteria (PDE / MACO / HBEL)
  • Support deviations, investigations & change controls
  • Collaborate with Manufacturing, QA, Engineering & Labs
  • Ensure compliance with FDA / EMA / cGMP requirements

Required Qualifications

  • Bachelor’s degree in Science or Engineering.
  • 5+ years of Cleaning Validation experience.
  • Strong knowledge of PDE / MACO calculations.
  • Experience with validation documentation.
  • cGMP pharmaceutical or biotech background.

Preferred Experience

  • Multi-product facilities
  • Biotech / sterile manufacturing
  • CIP / automated cleaning systems
  • HBEL / toxicological risk assessments

Core Skills

  • Technical writing
  • Risk-based decision making
  • Problem-solving & investigations
  • Cross-functional collaboration
  • Compliance-driven mindset

 

 

 

 

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