Hello,ย
I Hope you are doing great.ย ย
This isย Sonali Royย from Intellectt INC; weโve got an important Validation Engineer Support - North Haven, CT withย one of our prestigious clients. Interested candidates can please
send your updated resume atย sonali@intellectt.com
Job Title: Validation Engineer Support
Location: North Haven, CT
Job Description:
We are seeking an experienced Validation Engineer Support professional to oversee and optimize complex manufacturing processes for surgical devices in a high-volume production environment. This role involves leading validation activities, troubleshooting advanced electro-mechanical systems, and driving continuous improvement initiatives to ensure product quality and operational efficiency.
Key Responsibilities:
- Lead and execute equipment and process validations (IQ/OQ/PQ) for new and existing systems
- Troubleshoot complex automated systems including robotics, motion control, and machine vision
- Drive root cause analysis and implement corrective actions for equipment and process issues
- Lead NCMR and CAPA investigations to ensure compliance with quality standards
- Apply Lean principles to improve process efficiency and reduce waste
- Support equipment adaptation and optimization for manufacturing environments
- Perform statistical analysis including process capability, DOE, and process control
- Ensure component qualification through PPAP requirements
Required Qualifications:
- Bachelorโs degree in Electrical, Automation, Controls, Mechatronics, or related field
- 10+ years of manufacturing engineering/validation experience (8+ with Masterโs)
- Strong expertise in medical device process validation (IQ/OQ/PQ)
- Experience with statistical tools such as Minitab
- Hands-on experience with high-volume manufacturing assembly processes
- Strong troubleshooting skills in automation, robotics, and vision systems
- Solid understanding of PPAP and quality systems
ย
Thanks & Regards,
Sonali Roy
Talent Acquistion Specialist
Intellectt Incย
sonali@intellectt.com
Desk number: 732-979-2751*580