Role description:
Arcadis is seeking a CQV PM to manage the entire program for our client in Wisconsin.
Role accountabilities:
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Refine Program Level Strategy for assigned workstream
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Develop detailed activity planning and Level 3 Scheduling (with provided P6 Planner(s))
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Develop and implement CQV Plans, protocols, and procedures in compliance with regulatory requirements and industry standards.
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Develop and Implement FAT & SAT Strategies for assigned workstream (as needed)
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Communicate workstream status and monthly reporting requirements per Program level templates (intended audience is Owner Program and Owner WS PM's)
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Oversee the commissioning of equipment, systems, and utilities to ensure they are installed and functioning correctly.
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Conduct and document commissioning test and inspections
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Develop and execute qualification protocols (IQ/OQ/PQ) for equipment, systems and processes.
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Ensure all qualification activities are thoroughly documented and meet regulatory requirements
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Lead validation activities for manufacturing processes, cleaning procedures, and computer systems.
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Develop and execute validation protocols and reports, ensuring compliance with GMP and regulatory standards.
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Identify potential risks and develop mitigation strategies to ensure successful CQV activities.
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Ensure compliance with all health, safety, and environmental regulations
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Maintain accurate and up to date documentation for all CQV activities, including protocols, reports and deviations
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Work closely with project managers and others to ensure seamless integration of CQV activities with overall project plans.
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Identify opportunities for process optimization and implement improvements to enhance efficiency and compliance
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Stay updated with the latest advancements in CQV practices and regulatory requirements.
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Other duties as assigned
Qualifications & Experience:
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BS in Engineering, Life Sciences, or a related field.
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7+ years experience in CQV management, preferably in the pharmaceutical or biotechnology sector.
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Strong knowledge of GMP, FDA, and other regulatory environments
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Excellent project management and organizational skills
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Excellent problem solving and analytical skills, teamwork abilities and willingness to take on responsibilities beyond the traditional construction management role.
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Ability to read and interpret technical drawings and specifications
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Strong Communication and interpersonal skills
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Proficiency in CQV Software and tools including Kneat Software
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Professional certification in CQV or related field is a plus
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Ability to provide legal US work authorization documents required. Will consider US domestic travelers and relocation.
Arcadis offers benefits for full time and part time positions. These benefits include medical, dental, and vision, EAP, 401K, STD, LTD, AD&D, life insurance, paid parental leave, reward & recognition program and optional benefits including wellbeing benefits, adoption assistance and tuition reimbursement. We offer nine paid holidays and 15 days PTO that accrue per year. Salaries will vary and are based on several factors, such as experience, education, budget, internal equity, project and location.
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