CQV Engineer: GMP Validation & Commissioning Specialist

Arcadis; Massachusetts; On-site; USD 90,000 - 140,000; Full time

Job summary

Arcadis is seeking a CQV Engineer to support Commissioning, Qualification, and Validation activities for pharmaceutical and biotech projects in the United States. You will ensure equipment, facilities, utilities, and systems meet regulatory and operational requirements in GMP environments.

Responsibilities include developing CQV protocols, authoring IQ/OQ/PQ documents, and preparing URS/VMP/Final Reports. The role involves interfacing with Engineering, QA, Manufacturing, and Maintenance, and

Qualifications

• Bachelor’s Degree in Engineering required.
• 3-5 years of Equipment Validation experience in a cGMP & FDA regulated environment.
• Experience with CQV activities for equipment, systems, and utilities.

Responsibilities

• Develop and execute CQV protocols for equipment, facilities, and utilities.
• Author and review IQ, OQ, PQ documents.
• Prepare validation documents: URS, VMP, risk assessments, final reports.
• Troubleshoot equipment, utilities, and process deviations during qualification activities.
• Identify and implement improvements in CQV processes to enhance efficiency and compliance.
• Process validation turnover including EDMQ documentation and approvals.
• Perform validation for cleanrooms, HVAC, utilities, process equipment, laboratory instruments, and computerized systems.
• Support audits and regulatory inspections with required documentation.
• Collaborate with Engineering, QA, Manufacturing, and Maintenance teams and coordinate with vendors/contractors.

Skills

CQV expertise

GMP environments

IQ/OQ/PQ writing

Regulatory compliance

Troubleshooting CQV

Education

Bachelor’s Degree in Engineering

Tools

EDMQ

Job description

Arcadis is seeking a CQV Engineer to support Commissioning, Qualification, and Validation activities for pharmaceutical and biotech projects in the United States. You will ensure equipment, facilities, utilities, and systems meet regulatory and operational requirements in GMP environments.

Responsibilities include developing CQV protocols, authoring IQ/OQ/PQ documents, and preparing URS/VMP/Final Reports. The role involves interfacing with Engineering, QA, Manufacturing, and Maintenance, and