Process Validation Specialist

2 weeks ago


Billerica Massachusetts, United States Dew Software Full time
About the Role

Dew Software is seeking a highly skilled Process Validation Engineer to contribute to the success and growth of our Fortune 500 clients.

Key Responsibilities
  • Develop and execute process validation protocols, including IQ, OQ, and PQ, to ensure the quality and efficiency of our manufacturing processes.
  • Collaborate with cross-functional teams to identify process improvement opportunities and implement continuous improvement initiatives.
  • Analyze and interpret validation data to ensure compliance with industry standards, such as FDA, ISO, and GMP.
  • Conduct risk assessments and develop mitigation strategies to optimize manufacturing processes.
  • Work with external vendors to validate and qualify equipment and processes.
  • Ensure compliance with relevant regulatory requirements and standards.
  • Develop and maintain validation protocols, reports, and related documentation.
Requirements
  • Bachelor's degree in Engineering, preferably in Mechanical or Chemical Engineering.
  • Minimum of 3 years of experience in process validation in a manufacturing environment.
  • Strong understanding of process validation concepts and methodologies.
  • Experience with statistical analysis tools and techniques.
  • Knowledge of relevant regulatory requirements and standards.
  • Excellent problem-solving and analytical skills.
  • Strong attention to detail and ability to work under pressure.
  • Excellent written and verbal communication skills.


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