Validation Specialist

Arcadis is seeking a Validation Engineer that will be responsible for planning, executing, and documenting air flow visualization studies in controlled environments such as cleanrooms and laboratories, ensuring compliance with regulatory and industry standards. The role also requires hands-on experience with the Kneat digital validation platform to manage and automate the documentation and approval of validation protocols and reports. This individual will play a key role in supporting regulatory audits, continuous improvement initiatives, and digital transformation within the validation function

Collaborate with Facilities, Engineering, and Quality Assurance teams to resolve air flow issues and optimize HVAC performance.

Stay current with developments in air flow visualization techniques, validation technology, and regulatory expectations.

Identify and implement process improvements for validation efficiency, data integrity, and digital adoption.

Support the design and commissioning of new or modified controlled environments by providing air flow visualization expertise.

Develop, review, and manage electronic validation and qualification protocols (IQ/OQ/PQ, risk assessments, etc.) using the Kneat platform.

Maintain accurate and audit-ready documentation of all validation activities, including air flow visualization studies, within Kneat.

Prepare detailed reports, including annotated images and videos, demonstrating air flow behavior and identifying deviations or risks.

Plan, execute, and document air flow visualization (smoke) studies in cleanrooms, laboratories, and manufacturing areas.

Coordinate electronic review and approval workflows, ensuring timely completion and compliance with company SOPs.

Train and support colleagues in the effective use of Kneat for validation and compliance documentation.

Support internal and external regulatory inspections and audits by preparing and presenting validation records.

Analyze air flow patterns to verify compliance with ISO 14644, GMP, FDA, and internal company standards.

Ensure validation activities meet regulatory requirements and quality standards (GMP, FDA, EMA, ISO).

Minimum 2 years’ experience in validation, engineering, or quality assurance in a regulated environment (pharmaceutical, biotech, medical device, etc.).

Bachelor’s degree in Engineering, Life Sciences, Pharmaceutical Sciences, or a related discipline.

Excellent written and verbal communication skills, with the ability to produce clear and concise technical documentation.

Air Flow Visualization

Proficiency in Microsoft Office suite and basic data analysis.

At least 1 year of hands-on experience with the Kneat digital validation platform or similar electronic validation/document management systems.

Direct experience conducting air flow visualization (smoke) studies and cleanroom qualification.

Strong organizational skills and attention to detail.

Ability to provide legal US work authorization documents required. Will consider US domestic travelers and relocation.

Strong understanding of cleanroom standards (ISO 14644), GMP, and FDA/EMA regulatory requirements.

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.