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