Process Validation Engineer

1 Month ago • 3 Years + • Manufacturing

About the job

2 skills required for this role

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innovation

cross-functional

Job Description

Dew Software is looking for a Process Validation Engineer to join their team. The Process Validation Engineer will be responsible for developing and executing process validation protocols, collaborating with cross-functional teams, analyzing and interpreting validation data, and identifying and implementing continuous improvement initiatives. This role requires a Bachelor's degree in Engineering, preferably in Mechanical or Chemical Engineering, and at least 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, and knowledge of relevant regulatory requirements and standards are required.

Must have:

Bachelor's degree in Engineering
3+ years of experience in process validation
Strong understanding of process validation concepts
Experience with statistical analysis tools
Knowledge of regulatory requirements

Good to have:

Mechanical or Chemical Engineering degree
Experience with FDA, ISO, and GMP
Excellent problem-solving skills

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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.

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