CHENNAI · FULLTIME
Validation Engineer
Proffer It Consultancy
Chennai · onsite · Posted 1d ago
Sourced from
Undisclosed4–8 yrsfulltimeChennai
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Section · 01
About this role
Position Name:Validation Engineer
Location: Chennai
Experience: 4-8 Years
About BinQle
BinQle is a global delivery and execution partner supporting enterprises across the US, India, Singapore and Australia. We specialize in structured hiring, managed teams, and long-term delivery support.
Role Summary:
Responsible for leading and supporting manufacturing engineering initiatives, focusing on equipment and process validation in medical device manufacturing. Drives continuous improvement and ensures compliance with regulatory requirements.
What Youll Do:
- Lead and support manufacturing engineering projects from concept through implementation
- Design, develop, validate, and optimize manufacturing processes, workflows, and equipment
- Execute and document equipment qualification and process validation activities (IQ/OQ/PQ, FAT, SAT)
- Drive continuous improvement initiatives to enhance process capability, yield, and OEE
- Collaborate with cross-functional teams to achieve operational objectives and support NPI and technology transfers
- Provide technical expertise, mentorship, and post-release equipment support
- Ensure compliance with quality systems and regulatory standards in all activities
- Analyze production and process data to identify improvement opportunities
- Communicate project progress, risks, and recommendations to stakeholders
What We re Looking For (Must-Haves):
- At least 3 years experience in medical device equipment and process validation
- Hands-on experience with IQ/OQ/PQ, PFMEA, DOE, and validation documentation
- Experience in equipment qualification, process development, and OEE improvement
- Proficiency in SPC, process capability (Cp/Cpk), and CAPA
- Experience with Lean Six Sigma methodologies
- Ability to work 2nd shift (12:00-22:00)
Good to Have (Optional - only if mentioned):
- As per requirement
Qualifications:
Bachelors degree in biomedical, mechanical, electrical, or computer science engineering, or an equivalent qualification
Location: Chennai
Experience: 4-8 Years
About BinQle
BinQle is a global delivery and execution partner supporting enterprises across the US, India, Singapore and Australia. We specialize in structured hiring, managed teams, and long-term delivery support.
Role Summary:
Responsible for leading and supporting manufacturing engineering initiatives, focusing on equipment and process validation in medical device manufacturing. Drives continuous improvement and ensures compliance with regulatory requirements.
What Youll Do:
- Lead and support manufacturing engineering projects from concept through implementation
- Design, develop, validate, and optimize manufacturing processes, workflows, and equipment
- Execute and document equipment qualification and process validation activities (IQ/OQ/PQ, FAT, SAT)
- Drive continuous improvement initiatives to enhance process capability, yield, and OEE
- Collaborate with cross-functional teams to achieve operational objectives and support NPI and technology transfers
- Provide technical expertise, mentorship, and post-release equipment support
- Ensure compliance with quality systems and regulatory standards in all activities
- Analyze production and process data to identify improvement opportunities
- Communicate project progress, risks, and recommendations to stakeholders
What We re Looking For (Must-Haves):
- At least 3 years experience in medical device equipment and process validation
- Hands-on experience with IQ/OQ/PQ, PFMEA, DOE, and validation documentation
- Experience in equipment qualification, process development, and OEE improvement
- Proficiency in SPC, process capability (Cp/Cpk), and CAPA
- Experience with Lean Six Sigma methodologies
- Ability to work 2nd shift (12:00-22:00)
Good to Have (Optional - only if mentioned):
- As per requirement
Qualifications:
Bachelors degree in biomedical, mechanical, electrical, or computer science engineering, or an equivalent qualification
Disclaimer: This job posting has been aggregated from external source. Role details, content, and availability are subject to change. Applicants are advised to confirm the latest information directly on the company website before applying.
Sourced from naukri
Section · 02
Skills
process validationworkflowsmanufacturing engineeringsigmasix sigmaBiomedicalCAPAglobal deliveryprocess developmentEquipment QualificationCPKManufacturing ProcessesQuality SystemsNPIManufacturingcompliance