Senior Validation Engineer – Medical Devices, CAPA & GMP

Intellectt INC; North Haven (CT); On-site; USD 90,000 - 120,000; Full time

Job summary

Intellectt INC in North Haven, CT is seeking a Validation Engineer to drive validation activities across equipment and processes in a regulated setting. The role requires hands-on QA/QC expertise and collaboration with Quality, Manufacturing and Engineering teams.

Ideal candidates will bring 5+ years in validation, strong documentation skills, and a solid understanding of FDA, ISO 13485 and ISO 14971 regulations. This is an on-site position based in North Haven, CT.

Qualifications

• 5+ years of experience in Validation / Quality Engineering.
• Strong experience with IQ/OQ/PQ and Process/Equipment Validation.
• NCR and CAPA experience is mandatory.
• Hands-on experience with Root Cause Analysis (RCA).
• Experience in Medical Device / Pharmaceutical / regulated industry.
• Knowledge of FDA regulations, ISO 13485, and ISO 14971.
• Strong documentation and technical writing skills.

Responsibilities

• Develop and execute validation protocols and reports.
• Support equipment, process, and manufacturing validations.
• Investigate and resolve NCRs and support CAPA activities.
• Perform root cause investigations and implement corrective actions.
• Support deviations, change controls, risk assessments, and validation documentation.
• Work closely with Quality, Manufacturing, and Engineering teams.

Skills

Validation / Quality Engineering

IQ/OQ/PQ experience

NCR and CAPA experience

Root Cause Analysis

Regulatory knowledge

Documentation/Tech writing

Job description

Intellectt INC in North Haven, CT is seeking a Validation Engineer to drive validation activities across equipment and processes in a regulated setting. The role requires hands-on QA/QC expertise and collaboration with Quality, Manufacturing and Engineering teams.

Ideal candidates will bring 5+ years in validation, strong documentation skills, and a solid understanding of FDA, ISO 13485 and ISO 14971 regulations. This is an on-site position based in North Haven, CT.