Senior Validation Engineer - GMP/CSV (Kneat)

Syner G; Plainville (MA); On-site; USD 90,000 - 130,000; Full time

Job summary

Syner-G is seeking a Validation Engineer with 4–7 years of experience to support commissioning, qualification, validation (CQV), and CSV across equipment, utilities, facilities, laboratory systems, and manufacturing processes. The role emphasizes qualification records managed within the Kneat platform and strict adherence to GMP and data integrity standards.

You will collaborate with Engineering, Quality Assurance, and project teams to ensure timely, compliant validation execution, support

Qualifications

• Bachelor’s degree in life science, engineering, or related field.
• 4–7 years of experience in biotech, pharmaceutical, or medical device.
• Strong knowledge of FDA cGMP requirements, FMEA, and risk-based validation principles.
• Experience generating IQ/OQ/PQ/CSV reports and validation deliverables.

Responsibilities

• Develop, review, execute, and maintain validation protocols and reports in Kneat.
• Generate validation lifecycle documentation (IQ/OQ/PQ/CSV) for GMP systems.
• Prepare and review validation plans, risk assessments, and summary reports.
• Support technology transfer and change control activities with validation input.

Skills

Validation engineering

cGMP knowledge

FMEA

Risk assessment

IQ/OQ/PQ/CSV

Documentation

Communication

Independent work

Education

Bachelor’s degree in life science, engineering, or related field

Tools

Kneat

Job description

Syner-G is seeking a Validation Engineer with 4–7 years of experience to support commissioning, qualification, validation (CQV), and CSV across equipment, utilities, facilities, laboratory systems, and manufacturing processes. The role emphasizes qualification records managed within the Kneat platform and strict adherence to GMP and data integrity standards.

You will collaborate with Engineering, Quality Assurance, and project teams to ensure timely, compliant validation execution, support