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Process Validation Engineer

4 months ago

Billerica, United States Dew Software Full time
Job DescriptionJob Description

Dew Software is seeking a highly motivated and experienced Process Validation Engineer to join our team. As a leading software and technology company, we prioritize excellence and innovation in all aspects of our work. The Process Validation Engineer will play a critical role in ensuring the quality and efficiency of our manufacturing processes. This is an excellent opportunity to work with Fortune 500 clients and contribute to their success and growth.


Responsibilities
  • Develop and execute process validation protocols, including IQ, OQ, and PQ.
  • Collaborate with cross-functional teams to identify process improvement opportunities.
  • Analyze and interpret validation data to ensure compliance with industry standards.
  • Identify and implement continuous improvement initiatives to optimize manufacturing processes.
  • Conduct risk assessments and develop mitigation strategies.
  • 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, such as FDA, ISO, and GMP.
  • Excellent problem-solving and analytical skills.
  • Strong attention to detail and ability to work under pressure.
  • Excellent written and verbal communication skills.