Remote Validation Engineer – GMP, CSV & CQV Focus

BioSpace; Plainville (MA); Remote; USD 100,000 - 140,000; Full time

Job summary

Syner-G is seeking a Validation Engineer to support CQV and CSV activities across equipment, utilities, facilities, laboratory systems, and manufacturing processes. You will develop, execute, review, and maintain validation lifecycle documentation with a focus on Kneat-based workflows.

The role requires 4–7 years in biotech/pharma/medical devices, strong FDA cGMP knowledge, and hands-on validation experience. Collaboration with Engineering, QA, and Regulatory teams is essential.

Qualifications

• Bachelor’s degree in a life science, engineering, or related field.
• 4–7 years in biotech/pharma/medical device required.
• Strong knowledge of FDA cGMP, FMEA and risk-based validation.
• Hands-on validation experience with equipment, CSV, analytical methods and process validation.
• Experience writing IQ, OQ, PQ, and CSV reports.

Responsibilities

• Develop, review, and validate protocols and reports in Kneat.
• Create and close validation documents including IQ, OQ, PQ, and CSV.
• Support qualification of analytical lab equipment and manufacturing systems.
• Assist technology transfer through validation planning and execution.
• Collaborate with Engineering, QA, and Quality Control teams.
• Support deviations, CAPAs, change controls and inspections.
• Perform P&ID walkdowns and thermal mapping studies.
• Maintain GDP and data integrity standards.

Skills

cGMP knowledge

Validation lifecycle

Written verbal communication

Independent worker

Education

Bachelor's degree in life science/engineering

Tools

Kneat validation system

Job description

Syner-G is seeking a Validation Engineer to support CQV and CSV activities across equipment, utilities, facilities, laboratory systems, and manufacturing processes. You will develop, execute, review, and maintain validation lifecycle documentation with a focus on Kneat-based workflows.

The role requires 4–7 years in biotech/pharma/medical devices, strong FDA cGMP knowledge, and hands-on validation experience. Collaboration with Engineering, QA, and Regulatory teams is essential.