Arcadis · 4 weeks ago
CQV Engineer
Norton, MA
Full-time
Onsite
Mid Level
3+ years expArcadis is the world's leading company delivering sustainable design, engineering, and consultancy solutions for natural and built assets. They are seeking a CQV Engineer to support Commissioning, Qualification, and Validation (CQV) activities for a pharmaceutical/biotech client, ensuring compliance with regulatory and operational requirements.
Civil EngineeringConsultingWater
Hiring Manager
Natalie Hebert
Responsibilities
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
Support developing SOP’s
Other tasks as requested or required by Client to support Equipment Validation for each project
Qualification
Required
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
Previous Experience working in a cGMP and FDA regulated environment
Preferred
A strong understanding and knowledge of equipment and automated systems is desired
Benefits
Medical
Dental
Vision
EAP
401K
STD
LTD
AD&D
Life insurance
Paid parental leave
Reward & recognition program
Optional benefits including wellbeing benefits
Adoption assistance
Tuition reimbursement
Nine paid holidays
15 days PTO that accrue per year
Company
Arcadis
Arcadis is the world's leading company delivering sustainable design, engineering, and consultancy solutions for natural and built assets.
10001+ employees
H1B Sponsorship
Arcadis has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (126)
2024 (69)
2023 (69)
2022 (69)
2021 (72)
2020 (103)
Funding
Current Stage
Public CompanyTotal Funding
$0.03M2017-06-01Grant· $0.03M
1995-10-06IPO
Leadership Team
Alan Brookes
Chief Executive Officer
Neil McArthur
Chief Executive Officer
Recent News
2026-01-22
2026-01-20
Company data provided by crunchbase