Head of Engineering and Project Management
DPS Group LLC
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. Arcadis is seeking a CQV PM to manage the entire program for our client in Wisconsin.
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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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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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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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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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.
You'll do meaningful work, and no matter what role, you'll be helping to deliver sustainable solutions for a more prosperous planet. Our Commitment to Equality, Diversity, Inclusion & Belonging
We want you to be able to bring your best self to work every day which is why we take equality and inclusion seriously and hold ourselves to account for our actions. Women, minorities, people with disabilities and veterans are strongly encouraged to apply. We are dedicated to a policy of non-discrimination in employment on any basis including race, creed, color, religion, national origin, sex, age, disability, marital status, sexual orientation, gender identity, citizenship status, disability, veteran status, or any other basis prohibited by law.
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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