Junior Validation Engineer with CSV / CQV

IT Primeinc LLC; Cambridge (MA); On-site; USD 65,000 - 85,000; Full time

Job summary

IT Primeinc LLC in Cambridge, MA is seeking a Junior Validation Engineer skilled in CSV and CQV to help ensure compliant validation of pharmaceutical manufacturing equipment.

You will perform IQ/OQ/PQ activities, support MVPs and validation documents, and coordinate with QA to maintain GMP and 21 CFR Part 11 compliance.

Qualifications

• Experience performing validation and calibration activities for pharmaceutical manufacturing and sterile processing equipment in GMP and 21 CFR Part 11.
• Hands-on experience supporting MVPs, SOPs, validation protocols, and PPQ activities.
• Experience executing IQ, OQ, and PQ for manufacturing equipment.

Responsibilities

• Support MVPs, SOPs, validation protocols, and PPQ activities.
• Perform IQ, OQ, and PQ for manufacturing equipment.

Skills

Validation

Calibration

GMP compliance

Documentation

CQV basics

Job description

Junior Validation Engineer with CSV / CQV

Must-Have Skills:

Experience performing validation and calibration activities for pharmaceutical manufacturing and sterile processing equipment in compliance with GMP and 21 CFR Part 11 requirements.

Hands-on experience supporting Master Validation Plans (MVPs), SOPs, validation protocols, and Process Performance Qualification (PPQ) activities.

Experience executing Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) for manufacturing equipment.

Nice to Have Skills:

Experience with FDA regulations, data integrity, and computerized system validation (CSV).

Familiarity with risk assessments, deviation investigations, CAPA, and change control processes.