Senior CQV Engineer – GMP Validation Specialist

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) match on day one

Paid parental leave

Job summary

ProBio, a GenScript subsidiary, seeks a CQV specialist to support commissioning, qualification, and validation for GMP facilities, utilities, equipment, and systems. You will contribute to multiple client programs across clinical and commercial manufacturing in a fast-paced CDMO environment.

Responsibilities include developing IQ/OQ/PQ protocols, supporting CSV per GAMP5 and 21 CFR Part 11, and coordinating with Manufacturing, Engineering, QA, QC, and external vendors.

Qualifications

• BS/MS in life science with 4+ years in drug/biologics GMP production in validation/engineering roles.
• CQV experience for biotechnology/pharmaceutical facilities is required.
• Familiar with CSV per GAMP 5 and CFR Part 11.
• Experience in aseptic fill/finish equipment qualification and APS is preferred.
• Experience authoring validation protocols for utility and equipment.
• Familiar with GMP principles and cross-functional collaboration.

Responsibilities

• Execute CQV activities for facilities, utilities, process equipment, and manufacturing systems.
• Develop, review, and execute IQ, OQ, PQ protocols and validation reports.
• Support validation of facilities, utilities, equipment, processes, cleaning, and computer systems.
• Coordinate validation activities with Manufacturing, Engineering, QA, QC, Automation and external vendors.
• Participate in FAT, SAT, commissioning, equipment qualification, and facility expansion projects.
• Maintain validation documentation and ensure data integrity throughout the lifecycle.
• Support client audits, regulatory inspections, and internal quality audits.

Skills

GMP knowledge

Cross-functional collaboration

Documentation

Validation mindset

Education

BS/MS in life science

Tools

GAMP 5

CFR Part 11

Job description

ProBio, a GenScript subsidiary, seeks a CQV specialist to support commissioning, qualification, and validation for GMP facilities, utilities, equipment, and systems. You will contribute to multiple client programs across clinical and commercial manufacturing in a fast-paced CDMO environment.

Responsibilities include developing IQ/OQ/PQ protocols, supporting CSV per GAMP5 and 21 CFR Part 11, and coordinating with Manufacturing, Engineering, QA, QC, and external vendors.