Job Title: Validation Automation Engineer
Location: North Haven, CT
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, with a strong focus on qualification, documentation, troubleshooting, and cross-functional collaboration.
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 and maintain validation documentation, test records, and related quality documentation.
Required Qualifications
Strong experience in Validation Engineering.
Strong experience in Manufacturing Engineering.
Hands-on experience with automation equipment in a manufacturing environment.
Experience developing and executing IQ/OQ/PQ protocols and equipment qualification activities.
Experience working in medical device, pharmaceutical, or other regulated manufacturing environments.
Strong documentation and technical troubleshooting skills.
Ability to collaborate effectively with cross-functional engineering, manufacturing, quality, and operations teams.
Work Requirements
Experience working with automated manufacturing equipment in a regulated manufacturing environment.
Ability to support equipment validation, qualification, commissioning, and production activities.
Important Role Focus
This position does not require PLC programming or Controls Engineering experience. Candidates with strong Validation + Manufacturing Engineering + Automation Equipment experience are preferred over candidates whose background is primarily focused on PLC programming or Controls Engineering.
Equal Opportunity Employer
We are committed to providing equal employment opportunities to all qualified applicants and maintaining an inclusive workplace. Employment decisions are made without regard to legally protected characteristics.