Manufacturing Process Optimization Specialist

1 week ago


Billerica, Massachusetts, United States Dew Software Full time
Role Overview

We are seeking an experienced Manufacturing Process Optimization Specialist to join our team at Dew Software.

Job Description

As a key member of our organization, you will be responsible for developing process validation protocols, collaborating with cross-functional teams, and ensuring compliance with industry standards.

  • Develop process validation protocols, including IQ, OQ, and PQ, to ensure the quality and reliability of manufacturing processes.
  • Collaborate with cross-functional teams to identify process improvement opportunities and implement continuous improvement initiatives to optimize manufacturing processes.
  • Analyze and interpret validation data to ensure compliance with industry standards and regulatory requirements.
  • Conduct risk assessments and develop mitigation strategies to minimize risks associated with manufacturing processes.
  • Work with external vendors to validate and qualify equipment and processes to ensure their compatibility with our manufacturing operations.
  • Ensure compliance with relevant regulatory requirements and standards, such as FDA, ISO, and GMP.
Requirements

To be successful in this role, you will need:

  • A 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.
Estimated Salary Range

The estimated salary range for this position is $85,000 - $110,000 per year, depending on experience and qualifications.


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