Validation Automation Engineer

Job Details:

Title : Validation Automation Engineer

Location: North Haven, CT



Work Arrangement: On-site

Job Summary

We are seeking a Validation Automation Engineer with strong experience in Validation Engineering and Manufacturing Engineering within a regulated manufacturing environment. The ideal candidate will have hands-on experience with automation equipment, manufacturing processes, and equipment/system validation .

Key Responsibilities

• Execute equipment and process validation activities in a manufacturing environment.
• Develop and execute IQ/OQ/PQ protocols, validation plans, and validation reports .
• Support validation of automated manufacturing equipment and production systems .
• Collaborate closely with Manufacturing, Quality, Engineering, and Operations teams.
• Troubleshoot and resolve equipment and process issues during validation and production.
• Support commissioning, qualification, and implementation of manufacturing equipment.
• Ensure validation activities comply with GMP, FDA, and applicable quality standards .
• Prepare, review, and maintain validation documentation, test records, and related technical documentation .

Required Qualifications

• Strong experience in Validation Engineering .
• Strong experience in Manufacturing Engineering .
• Hands-on experience with automation equipment in a manufacturing environment .
• Experience with IQ/OQ/PQ and equipment qualification .
• Experience in medical device, pharmaceutical, or other regulated manufacturing environments .
• Strong documentation, troubleshooting, problem-solving, and cross-functional collaboration skills.

Important Note

PLC programming and Controls Engineering experience are not required.

Priority will be given to candidates with strong Validation + Manufacturing Engineering + Automation Equipment experience rather than candidates with primarily PLC/Controls Engineering backgrounds.