Validation Automation Engineer
Intellectt INC
Job Details:
Title : Validation Automation Engineer
Location: North Haven, CT
Work Arrangement: On-site
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 .
- 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.
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.
Vacancy posted 1 day ago
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