Commissioning, Qualification & Validation (CQV) Specialist — Packaging Equipment

Job overview

The Commissioning, Qualification & Validation (CQV) Specialist — Packaging Equipment role is onsite in New Albany, OH. Compensation is not specified. The specialist supports packaging equipment and systems in a biotechnology manufacturing environment. The role helps ensure packaging lines are installed, tested, qualified, and documented in line with GMP, FDA, and internal quality requirements, while supporting project schedules and startup activities.

What you'll do

• Support commissioning, qualification, and validation of primary and secondary packaging equipment
• develop, review, and execute IQ/OQ/PQ protocols and related documentation
• verify installation and operational readiness of packaging equipment and utilities
• coordinate with engineering, quality assurance, validation, manufacturing, and vendors
• support deviations, discrepancy resolution, risk assessments, test planning, FAT/SAT, startup, troubleshooting, and validated-system turnover documentation
• follow cGMP, FDA, and company validation procedures.

What we're looking for

Skills & competencies

cqv specialist

packaging equipment

commissioning

qualification

validation

biotechnology

gmp

fda compliance

iq/oq/pq

fat/sat

new albany oh

pinnaql

extended hours

weekend and holiday availability

Work arrangement

• Weekend coverage required

Why this role

The posting seeks 5+ years of CQV, validation, or commissioning experience in pharmaceutical or biotechnology manufacturing and 2+ years qualifying packaging-line equipment; extended hours, weekends, and holidays may be required.

About the employer

Pinnaql is hiring for this role. Industry: Industrial Design Services. Sector: 54.