CQV Engineer

Description

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

Requirements

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.

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

Benefits

You’ll do meaningful work, and no matter what role, you’ll be helping to deliver sustainable solutions for a more prosperous planet. Make your mark, on your career, your colleagues, your clients, your life and the world around you.

Arcadis offers benefits for full time and part time positions. These benefits include medical, dental, and vision, EAP, 401K, STD, LTD, AD&D, life insurance, paid parental leave, reward & recognition program and optional benefits including wellbeing benefits, adoption assistance and tuition reimbursement. We offer nine paid holidays and 15 days PTO that accrue per year. Salaries will vary and are based on several factors, such as experience, education, budget, internal equity, project and location.

Training + Development

Interview process

Visa Sponsorship

Security clearance