GMP Validation Engineer (CSV) - Kneat Specialist

Syner-G BioPharma Group; Plainville (MA); On-site; USD 90,000 - 140,000; Full time

Job summary

Syner-G BioPharma Group in Plainville, MA is seeking a Validation Engineer with 4-7 years experience to support CQV and CSV activities across equipment, utilities, facilities, and lab systems. The role emphasizes qualification lifecycle documentation within the Kneat platform and GMP compliance.

You will collaborate with Engineering, Manufacturing, Quality Assurance, and project teams to ensure timely execution, change control, and data integrity.

Qualifications

• Excellent written and verbal communication skills.
• Ability to work independently in a regulated environment.
• Strong organizational and documentation skills.
• Experience communicating with cross-functional teams.

Responsibilities

• Develop, review, execute, and maintain commissioning, qualification, and validation protocols and reports within Kneat.
• Generate and execute validation lifecycle documentation, including FAT, SAT, IQ, OQ, PQ, and CSV deliverables.
• Author, execute, review, and close validation documents including validation plans and reports.
• Support qualification and validation activities for analytical laboratory equipment and computerized systems.
• Support technology transfer projects through validation planning and execution.

Skills

Communication skills

Detail-oriented

Independent worker

Problem solving

Education

Bachelor’s degree in life science or engineering

Job description

Syner-G BioPharma Group in Plainville, MA is seeking a Validation Engineer with 4-7 years experience to support CQV and CSV activities across equipment, utilities, facilities, and lab systems. The role emphasizes qualification lifecycle documentation within the Kneat platform and GMP compliance.

You will collaborate with Engineering, Manufacturing, Quality Assurance, and project teams to ensure timely execution, change control, and data integrity.