DPS Group Global · 4 hours ago
CQV Project Manager
Kenosha, WI
Full-time
Onsite
Senior Level
7+ years expArcadis is the world's leading company delivering sustainable design, engineering, and consultancy solutions for natural and built assets. They are seeking a CQV Project Manager to manage the entire program for their client in Wisconsin, focusing on developing and implementing CQV plans and ensuring compliance with regulatory requirements.
Industrial AutomationIndustrial EngineeringProject Management
Responsibilities
Refine Program Level Strategy for assigned workstream
Develop detailed activity planning and Level 3 Scheduling (with provided P6 Planner(s))
Develop and implement CQV Plans, protocols, and procedures in compliance with regulatory requirements and industry standards
Develop and Implement FAT & SAT Strategies for assigned workstream (as needed)
Communicate workstream status and monthly reporting requirements per Program level templates (intended audience is Owner Program and Owner WS PM’s)
Oversee the commissioning of equipment, systems, and utilities to ensure they are installed and functioning correctly
Conduct and document commissioning test 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
Work closely with project managers and others to ensure seamless integration of CQV activities with overall project plans
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
Qualification
Required
BS in Engineering, Life Sciences, or a related field
7+ years experience in CQV management, preferably in the pharmaceutical or biotechnology sector
Strong knowledge of GMP, FDA, and other regulatory environments
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
Ability to provide legal US work authorization documents required
Preferred
Professional certification in CQV or related field is a plus
Benefits
Medical
Dental
Vision
EAP
401K
STD
LTD
AD&D
Life insurance
Paid parental leave
Reward & recognition program
Optional benefits including wellbeing benefits
Adoption assistance
Tuition reimbursement
Nine paid holidays
15 days PTO that accrue per year
Company
DPS Group Global
DPS is a global consulting, engineering and construction management company, serving high-tech industries around the world.
1001-5000 employees
H1B Sponsorship
DPS Group Global has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (6)
2024 (15)
2023 (30)
2022 (28)
2021 (16)
2020 (15)
Funding
Current Stage
Late StageTotal Funding
unknown2022-10-05Acquired
Recent News
2022-10-06
Company data provided by crunchbase