CQV Manager
Apply NowCompany: DPS Group
Location: Indianapolis, IN 46253
Description:
About The Job
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. Everyone has an important role to play. With the power of many curious minds, together we can solve the world's most complex challenges and deliver more impact together.
Role description:
Arcadis is seeking a CQV Manager to develop the CQV strategy and organizational structure for all CQV activities for the new pharmaceutical manufacturing facility.
Role accountabilities:
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
Qualifications & Experience:
BS in Engineering, Life Sciences, or a related field.
8+ years experience in CQV management, preferably in the pharmaceutical or biotechnology sector.
CQV Manager
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. Will consider US domestic travelers and relocation.
Why Arcadis?
We can only achieve our goals when everyone is empowered to be their best. We believe everyone's contribution matters. It's why we are pioneering a skills-based approach, where you can harness your unique experience and expertise to carve your career path and maximize the impact we can make together.
You'll do meaningful work, and no matter what role, you'll be helping to deliver sustainable solutions for a more prosperous planet. Make your mark, on your career, your colleagues, your clients, your life and the world around you.
Together, we can create a lasting legacy.
Join Arcadis. Create a Legacy.
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. Our ambition is to be an employer of choice and provide a great place to work for all our people. We are an equal opportunity and affirmative action employer. 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.
#LI-SG1
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. Everyone has an important role to play. With the power of many curious minds, together we can solve the world's most complex challenges and deliver more impact together.
Role description:
Arcadis is seeking a CQV Manager to develop the CQV strategy and organizational structure for all CQV activities for the new pharmaceutical manufacturing facility.
Role accountabilities:
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
Qualifications & Experience:
BS in Engineering, Life Sciences, or a related field.
8+ years experience in CQV management, preferably in the pharmaceutical or biotechnology sector.
CQV Manager
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. Will consider US domestic travelers and relocation.
Why Arcadis?
We can only achieve our goals when everyone is empowered to be their best. We believe everyone's contribution matters. It's why we are pioneering a skills-based approach, where you can harness your unique experience and expertise to carve your career path and maximize the impact we can make together.
You'll do meaningful work, and no matter what role, you'll be helping to deliver sustainable solutions for a more prosperous planet. Make your mark, on your career, your colleagues, your clients, your life and the world around you.
Together, we can create a lasting legacy.
Join Arcadis. Create a Legacy.
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. Our ambition is to be an employer of choice and provide a great place to work for all our people. We are an equal opportunity and affirmative action employer. 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.
#LI-SG1