Validation Automation Engineer

Job Summary

Seeking a Validation Automation Engineer with strong Validation Engineering and Manufacturing Engineering experience in a regulated manufacturing environment. The role requires hands-on experience with automation equipment, manufacturing processes, and equipment/system validation. The engineer will support equipment and process validation, qualification, commissioning, troubleshooting, and implementation while maintaining required quality and validation documentation.

Responsibilities

• Execute equipment and process validation activities in a manufacturing environment.
• Develop and execute IQ/OQ/PQ protocols, validation plans, and reports.
• Support validation of automated manufacturing equipment and production systems.
• Collaborate 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 and maintain validation documentation and test records.

Required Qualifications

• Strong Validation Engineering experience.
• Strong Manufacturing Engineering experience.
• 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, and cross-functional collaboration skills.

Work Requirements

• Onsite position in North Haven, CT.
• PLC programming and Controls Engineering experience is not required.
• Candidates with strong Validation + Manufacturing + Automation Equipment experience are preferred over pure PLC/Controls profiles.

Equal Opportunity Employer

We are an equal opportunity employer and consider qualified applicants without regard to legally protected characteristics.

Benefits

No benefits will be provided other than the stated pay rate, as this is a contract position.