Process Validation Engineer

Dew Software
Billerica, MA, US
Full-time

Job Description

Job 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.
  • 30+ days ago
Related jobs
Dew Software
Billerica, Massachusetts

The Process Validation Engineer will play a critical role in ensuring the quality and efficiency of our manufacturing processes. Dew Software is seeking a highly motivated and experienced Process Validation Engineer to join our team. Develop and execute process validation protocols, including IQ, OQ...

Dew Software
Billerica, Massachusetts

The Process Validation Engineer will play a critical role in ensuring the quality and efficiency of our manufacturing processes. Dew Software is seeking a highly motivated and experienced Process Validation Engineer to join our team. Develop and execute process validation protocols, including IQ, OQ...

Katalyst HealthCares & Life Sciences
Billerica, Massachusetts

Manufacturing Engineering Support / Engineering Documentation. Process Layout, Modelling, and Documentation. Process Development and Characterization. Test Method Development and Validation. ...

Promoted
Raytheon
Everett, Massachusetts

Master of Science (MS) in mechanical engineering or electrical engineering. The RF Mechanical Team at Raytheon is seeking a talented Senior Engineer to join our team in Tucson, AZ. We bring the strength of more than 100 years of experience and renowned engineering expertise to meet the needs of toda...

Promoted
PMI (Project Management Institute)
Boston, Massachusetts

JobPosting","title":"QA & Automation Engineer III","datePosted":"2024-09-04T00:00:00","validThrough":null,"description":"QA Automation Engineer (Multiple Openings), Project Management Institute, Inc. QA Automation Engineer (Multiple Openings), Project Management Institute, Inc. Newtown Square, PA: P...

Promoted
Communications & Power Industries LLC
Stow, Massachusetts

CPI Radant Technologies is actively seeking a qualified individual to join our team as a Manufacturing Quality Engineer II, specializing in composite products for both commercial and government programs within the Aerospace industry. The ideal candidate will have a strong background in aerospace eng...

Promoted
Watts Water Technologies
North Andover, Massachusetts

As the Project Manager, you will collaborate with sales, technical support, field engineering teams, and customer IT and operations staff to install, configure, and provision The Detection Group's Trident System. Project Management experience, or an equivalent combination of education and experience...

Promoted
Draper Labs
Cambridge, Massachusetts

System I&T Engineers leverage multi-disciplinary engineering expertise and collaborate with other Systems Engineers to establish clear, verifiable, and traceable requirements, inform and drive system concepts, architectures, and designs to promote testability, and utilizes resident expertise and les...

Promoted
IMEG Corporation
Boston, Massachusetts

Mechanical Engineer Designer - New Graduate. The Mechanical Engineer Designer will perform calculations, system design, equipment selections, reports, progress submittals and BIM instructions for their project to assure project completeness and accuracy within the allocated period and monetary budge...

Promoted
Raytheon Careers
Andover, Massachusetts

This is a 2nd Shift position*Test and Validation Engineers develop and improve test processes analyzing product specifications to determine appropriate designs and processes to support customer requirements. You would apply your knowledge and skills to develop, test, modify, and create solutions thr...