Senior CQV Validation Engineer

ProBio; Pennington (NJ); On-site; USD 80,000 - 120,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

401(k) with company match

Paid parental leave

Paid time off

Job summary

GenScript USA Inc/ProBio Inc. is seeking a senior CQV professional to support commissioning, qualification, and validation for GMP manufacturing facilities, utilities, equipment, and processes. You will work across multiple client programs in a fast-paced CDMO environment to ensure cGMP compliance and data integrity.

The role reports to the Sr. Validation Manager and requires comprehensive CQV/ CSV experience in biotechnology and pharmaceutical production.

Qualifications

• BS/MS in life science with 9 years' GMP validation/engineering experience.
• Experience in CQV for biotech/pharma facilities.
• Familiar with GAMP 5 and CFR Part 11 CSV.
• Ability to work across functional groups for team collaboration.

Responsibilities

• Execute CQV activities for facilities, utilities, equipment, and manufacturing systems.
• Develop, review, and execute IQ, OQ, PQ protocols and validation reports.
• Support validation activities including CSV, deviation investigations, CAPAs, change controls and risk assessments.
• Coordinate validation activities with Manufacturing, Engineering, QA, QC, Automation, and external vendors.
• Participate in FAT, SAT, commissioning, and facility expansion projects.

Skills

CQV experience

CSV

GAMP 5

Regulatory awareness

Cross-functional collaboration

Education

BS/MS in life science

Job description

GenScript USA Inc/ProBio Inc. is seeking a senior CQV professional to support commissioning, qualification, and validation for GMP manufacturing facilities, utilities, equipment, and processes. You will work across multiple client programs in a fast-paced CDMO environment to ensure cGMP compliance and data integrity.

The role reports to the Sr. Validation Manager and requires comprehensive CQV/ CSV experience in biotechnology and pharmaceutical production.