CQV Project Manager

DPS Engineering • Kenosha, WI

143d

About The Position

Arcadis is seeking a CQV Manager to develop the CQV strategy and organizational structure for all CQV activities for the new pharmaceutical manufacturing facility.

Requirements

• 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.

Nice To Haves

• Will consider US domestic travelers and relocation.

Responsibilities

• 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

What This Job Offers

• Career Level: Mid Level
• Industry: Professional, Scientific, and Technical Services
• Education Level: Bachelor's degree
• Number of Employees: 501-1,000 employees