CQV Engineer

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.

Arcadis is seeking a Validation Engineer to support commissioning, qualification, validation, requalification, and lifecycle management activities for manufacturing, laboratory, utility, facility, and quality systems within a GMP-regulated pharmaceutical environment. The Validation Engineer will be responsible for developing and executing validation documentation, supporting capital projects, managing change controls, coordinating cross-functional activities, and ensuring compliance with applicable regulatory, quality, and company requirements. This role supports equipment, utility, facility, and process validation activities from design through operational readiness.

• Execute commissioning, qualification, and validation (CQV) activities for manufacturing equipment, laboratory systems, facilities, and utilities.
• Author, execute, and review FAT, SAT, IQ, OQ, PQ, requalification protocols, traceability matrices (RTMs), and validation reports.
• Support periodic reviews, assessments, and requalification programs to maintain validated state.
• Ensure validation activities are completed in alignment with GMP, quality, and regulatory requirements.
• Support validation readiness for manufacturing operations and capital projects.

• Develop, review, and update technical documentation including specifications, SOPs, risk assessments, investigations, engineering drawings, and validation deliverables.
• Create and manage lifecycle documentation including User Requirements Specifications (URS), Functional Specifications, Impact Assessments, and Validation Summary Reports.
• Review and provide redlines for engineering and validation documentation.

• Coordinate validation activities with Manufacturing, Facilities, Quality Control, Material Operations, Engineering, Automation, and Quality Assurance teams.
• Monitor validation schedules and support achievement of department milestones and metrics.
• Participate in technical reviews, risk assessments, project meetings, and mitigation planning activities.

• Author, execute, review, and support GMP change controls.
• Participate in deviation investigations, technical investigations, CAPAs, and non-conformance resolution activities.
• Ensure all activities comply with company procedures, GMP requirements, and regulatory expectations.
• Support audit and inspection readiness activities.

• Support commissioning, startup, and qualification activities associated with capital projects and facility expansions.
• Assist with system turnover, operational readiness, and startup activities.
• Support manufacturing operations during project execution, shutdowns, and system transitions.

• Provide technical troubleshooting support during validation and qualification activities.
• Investigate equipment, utility, process, and facility issues impacting qualification or manufacturing readiness.
• Support continuous improvement initiatives to enhance compliance, reliability, and operational efficiency.

• Support planned facility shutdown and startup activities.
• Participate in operational and coordination meetings.
• Provide status updates, progress reports, and performance metrics as required.
• Support manufacturing operations during regular and off-shift activities as needed.
• Other duties as assigned

• Bachelor's degree in Chemical Engineering, Biomedical Engineering, Biotechnology, Mechanical Engineering, Electrical Engineering, Automation Engineering, Industrial Engineering, or a related scientific discipline.
• Experience supporting validation and qualification activities in a GMP-regulated pharmaceutical,…