Role description: Arcadis is seeking a CQV Manager to develop the CQV strategy and organizational structure for all CQV activities for the new pharmaceutical manufacturing facility. Role accountabilities: * Lead and manage CQV activities for the new pharmaceutical manufacturing facility. * Develop and implement CQV plans, protocols, and procedures in compliance with regulatory requirements and industry standards. * Oversee the commissioning of equipment, systems, and utilities to ensure they are installed and functioning correctly. * Conduct and document commissioning tests and inspections. * Develop and execute qualification protocols (IQ/OQ/PQ) for equipment, systems, and processes. * Ensure all qualification activities are thoroughly documented and meet regulatory requirements. * Lead validation activities for manufacturing processes, cleaning procedures, and computer systems. * Develop and execute validation protocols and reports, ensuring compliance with GMP and regulatory standards. * Identify potential risks and develop mitigation strategies to ensure successful CQV activities. * Ensure compliance with all health, safety, and environmental regulations. * Maintain accurate and up-to-date documentation for all CQV activities, including protocols, reports, and deviations. * Prepare and present progress reports and updates to project management and stakeholders. * Work closely with project managers, engineers, and other stakeholders to ensure seamless integration of CQV activities with overall project plans. * Maintain effective communication with regulatory agencies and ensure timely submission of required documentation. * Identify opportunities for process optimization and implement improvements to enhance efficiency and compliance. * Stay updated with the latest advancements in CQV practices and regulatory requirements. * Other duties as assigned Qualifications & Experience: * BS in Engineering, Life Sciences, or a related field. * 8+ years experience in CQV management, preferably in the pharmaceutical or biotechnology sector. * Strong knowledge of GMP, FDA, and other regulatory requirements. * Excellent project management and organizational skills. * Excellent problem-solving and analytical skills, teamwork abilities and willingness to take on responsibilities beyond the traditional construction management role. * Ability to read and interpret technical drawings and specifications. * Strong communication and interpersonal skills. * Proficiency in CQV software and tools including KNEAT Software. * Professional certification in CQV or related field is a plus. * Ability to provide legal US work authorization documents required. Will consider US domestic travelers and relocation #LI-SG1