CQV Engineer

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 (CQV) activities for a pharmaceutical/biotech client. This role will be responsible for ensuring that equipment, facilities, utilities, and systems comply with regulatory and operational requirements. The ideal candidate will have experience in GMP environments and expertise in commissioning, qualification, and validation processes for manufacturing and laboratory systems.

• Develop and execute commissioning, qualification, and validation (CQV) protocols for equipment, facilities, and utilities.
• Author and review Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) documents.
• Prepare and execute validation documents, including User Requirement Specifications (URS), Validation Master Plans (VMP), Risk Assessments, and Final Reports.
• Provide expertise in troubleshooting equipment, utilities, and process deviations during qualification activities.
• Identify and implement improvements in CQV processes to enhance efficiency and compliance.
• Preparation and processing of turnover packaging and validation documentation in EDMQ (electronic document management system).
• Provide support for generation, resolution and closure of Equipment Validation related deviations and required documentation
• Perform validation activities for cleanrooms, HVAC, utilities, process equipment, laboratory instruments, and computerized systems.
• Ensure all CQV activities align with FDA 21 CFR Part 11, Part 210/211, EU GMP Annex 15, and other regulatory requirements.
• Conduct risk assessments and gap analyses to identify compliance risks and propose mitigation strategies.
• Support audits and regulatory inspections by providing required documentation and responses.
• Work closely with Engineering, Quality Assurance, Manufacturing, and Maintenance teams to ensure smooth execution of CQV activities.
• Coordinate with vendors and contractors for equipment qualification and commissioning.
• Other tasks as requested or required by Client to support Equipment Validation for each project.

Qualifications & Experience:

• Bachelor’s Degree in Engineering (Mechanical, Chemical, Biomedical, or related field).
• 3-5 Years of Equipment Validation experience working within a cGMP & FDA Regulated environment
• Previous experience with CQV activities for equipment outlined above.
• Supporting engineer will be resident at the Client facility or a previously agreed upon location (i.e. vendor’s location).
• Experience with FDA, EU, and ICH regulatory requirements for qualification and validation.
• Hands-on experience with utilities, process equipment, HVAC, cleanrooms, and laboratory systems.
• Proficiency in writing IQ, OQ, PQ, and validation reports.
• A strong understanding and knowledge of equipment and automated systems is desired.
• Support to be performed as required by the project schedules
• Previous Experience working in a cGMP and FDA regulated environment