CQV Engineer

About The Job

Arcadis is the world's leading company delivering sustainable design, engineering, and consultancy solutions for natural and built assets.

We are more than 36,000 people, in over 70 countries, dedicated to improving quality of life. Everyone has an important role to play. With the power of many curious minds, together we can solve the world’s most complex challenges and deliver more impact together.

Role 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.

Role accountabilities:

• 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.

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

Why Arcadis?

We can only achieve our goals when everyone is empowered to be their best. We believe everyone's contribution matters. It’s why we are pioneering a skills-based approach, where you can harness your unique experience and expertise to carve your career path and maximize the impact we can make together.

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.

Together, we can create a lasting legacy.

Join Arcadis. Create a Legacy.

Our Commitment to Equality, Diversity, Inclusion & Belonging

We want you to be able to bring your best self to work every day which is why we take equality and inclusion seriously and hold ourselves to account for our actions. Our ambition is to be an employer of choice and provide a great place to work for all our people. We are an equal opportunity and affirmative action employer. Women, minorities, people with disabilities and veterans are strongly encouraged to apply. We are dedicated to a policy of non-discrimination in employment on any basis including race, creed, color, religion, national origin, sex, age, disability, marital status, sexual orientation, gender identity, citizenship status, disability, veteran status, or any other basis prohibited by law.

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.