Cleaning Validation Professional

2 weeks ago


Largo, Florida, United States Formulated Solutions Full time
Job Description

Company Overview

Formulated Solutions is a leading provider of innovative solutions for the Pharmaceutical and Self-Directed Consumer Healthcare industries.

Job Summary

The Cleaning Validation Engineer will be responsible for ensuring that cleaning validation activities within commercial and development facilities are compliant with both internal and regulatory standards.

Key Responsibilities

  • Develop and maintain cleaning validation strategies compliant with US FDA requirements
  • Create cleaning cycle development programs for various equipment
  • Evaluate manufacturing process documents and equipment cleaning procedures
  • Lead investigations and troubleshooting problems during cleaning
  • Plan and execute onsite cleaning validation programs
  • Compile and analyze validation data for submittal
  • Lead resolution of cleaning deviations
  • Collaborate with other departments to define protocol contents and actions
  • Develop and author change controls for cleaning process or equipment changes
  • Write and execute IQ/OQ/PQ and cycle development protocols

Requirements

  • Bachelor's Degree or equivalent in a scientific/pharmaceutical area
  • 5+ years of cleaning validation or engineering work in GMP and FDA regulated environment
  • Ability to generate protocols and reports for evaluation experiments
  • Advanced knowledge of analytical equipment and techniques
  • Understanding of regulatory requirements related to cleaning validation
  • Experience in risk management and client service/project management
  • Demonstrated ability to work independently and in a team environment
  • Familiarity with production equipment and processing technologies


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