Senior Validation Engineer – CQV for GMP Biotech

GenScript/ProBio; Pennington (NJ); On-site; USD 90,000 - 120,000; Full time

Benefits offered by this job

Medical, dental, and vision insurance

401(k) retirement plan with company match

Flexible paid time off

Job summary

GenScript/ProBio in Pennington, New Jersey, is hiring a Validation Engineer to support commissioning, qualification, and validation (CQV) activities. The ideal candidate will have a BS/MS in life sciences and at least 9 years of experience in the GMP production environment.

This position involves executing validation protocols, supporting technology transfers, and coordinating validation with various teams. Benefits include medical insurance, a 401(k) plan with match, and flexible paid time off.

Qualifications

• Minimum 9 years of experience in drug/biologics industry, especially in GMP settings.
• Experience with CSV per GAMP 5 and CFR Part 11 is required.
• Familiarity with cleaning and process validation is a plus.

Responsibilities

• Execute CQV activities for facilities, process equipment, and manufacturing systems.
• Support technology transfer for new client programs.
• Prepare validation documentation per regulatory standards.

Skills

CQV activities

GMP production experience

Collaboration across functional groups

Validation documentation

Education

BS/MS in life science or related field

Job description

GenScript/ProBio in Pennington, New Jersey, is hiring a Validation Engineer to support commissioning, qualification, and validation (CQV) activities. The ideal candidate will have a BS/MS in life sciences and at least 9 years of experience in the GMP production environment.

This position involves executing validation protocols, supporting technology transfers, and coordinating validation with various teams. Benefits include medical insurance, a 401(k) plan with match, and flexible paid time off.