CQV Manager

Arcadis; Philadelphia (Philadelphia County); On-site; USD 120,000 - 180,000; Full time

Benefits offered by this job

Medical

Dental

Vision

401K

STD

LTD

AD&D

Life insurance

Paid parental leave

Tuition reimbursement

Job summary

Arcadis seeks an experienced CQV Project Manager to lead commissioning, qualification and validation activities for major pharmaceutical technology transfer projects in the United States. The role demands oversight from FEL-3 through Performance Qualification, ensuring schedule adherence, budget control, and regulatory compliance within GMP environments.

Ideal candidates bring extensive CQV program management experience, cross-functional leadership, and familiarity with single-use tech, MES

Qualifications

• 7-10 years’ experience in CQV, validation, commissioning, or PM in GMP environments.
• 5+ years leading CQV programs, capital projects, or tech transfers.

Responsibilities

• Lead CQV activities from design through startup and PQ.
• Act as primary CQV contact across stakeholders and vendors.
• Develop and execute CQV deliverables (URS, IQ/OQ/PQ, DQA, Test Plans, RTM).
• Oversee commissioning, qualification, validation, startup for equipment and MES/EBR systems.
• Collaborate with Engineering, Quality, Validation, Operations on reviews, risk, change control, FAT/SAT.

Skills

CQV experience

Project management

GMP knowledge

Stakeholder management

Validation lifecycle

Education

Bachelor's degree in Engineering/Life Sciences

Job description

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.

Arcadis is seeking an experienced CQV Project Manager to lead Commissioning, Qualification & Validation activities for a large-scale pharmaceutical manufacturing technology transfer project involving the relocation and expansion of derivatization, conjugation, and alum adsorption processes. This role will provide strategic leadership and oversight from FEL-3 through Performance Qualification, ensuring successful execution of CQV deliverables, schedule adherence, budget management, and regulatory compliance. The ideal candidate will have extensive experience managing CQV programs within GMP regulated pharmaceutical or biotechnology environments, leading cross‑functional teams, and supporting major capital projects, facility expansions, and technology transfers. This individual will serve as the primary CQV lead, driving project execution, stakeholder alignment, and operational readiness while supporting implementation of single‑use technologies, MES integration, and electronic batch records.

Responsibilities

• Lead and manage all CQV project activities from design through startup and Performance Qualification, including CQV execution strategy, schedules, resource plans, budgets, and risk mitigation plans.
• Serve as the primary point of contact for CQV activities across project stakeholders, clients, vendors, contractors, and internal teams, ensuring alignment on scope, deliverables, milestones, and project performance.
• Direct the development, review, approval, and execution of CQV deliverables, including CQP, URS, SLIA, CLIA, DQA, Test Plans, RTM, Equipment Turnover Checklists, IQ/OQ/PQ protocols, and summary reports.
• Oversee commissioning, qualification, validation, and startup activities for process equipment, utility systems, manufacturing systems, single‑use technologies, MES platforms, and electronic batch records.
• Collaborate with Engineering, Manufacturing, Automation, Quality, Validation, Operations, and Project Controls teams to support design reviews, technical reviews, risk assessments, change control, FAT/SAT, system turnover, readiness reviews, and transition to operations.
• Ensure compliance with cGMP, FDA, ISPE, ASTM, and GAMP guidelines while managing deviations, CAPAs, change controls, validation exceptions, inspection readiness, regulatory audits, client reviews, and quality assessments.
• Support technology transfer activities from development through commercial manufacturing, including process validation, process simulation, operational readiness, and successful manufacturing startup.
• Other duties as assigned

Qualifications & Experience

• Bachelor's Degree in Engineering, Life Sciences, Biotechnology, or related technical discipline.
• 7 - 10 years’ experience of CQV, Validation, Commissioning, or Project Management experience within GMP-regulated pharmaceutical or biotechnology environments.
• 5+ years leading CQV programs, capital projects, facility expansions, or technology transfers, with demonstrated experience managing project schedules, budgets, resources, and multidisciplinary teams.
• Strong understanding of validation lifecycle management, CQV best practices, FAT, SAT, IOC, IQ, OQ, PQ execution, process equipment qualification, critical utilities, GMP manufacturing operations, change control, deviation management, quality systems, and risk management.
• Preferred experience supporting biologics, vaccine, or sterile manufacturing facilities, including tangential flow filtration, single‑use technologies, conjugation processes, downstream manufacturing systems, MES platforms, electronic batch records, data integrity initiatives, eVal or other electronic validation systems, and EPCM project delivery models.
• Experience supporting large‑scale technology transfer and manufacturing startup projects preferred; PMP certification preferred.
• 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.

• medical
• dental
• vision
• EAP
• 401K
• STD
• LTD
• AD&D
• life insurance
• paid parental leave
• reward & recognition program
• wellbeing benefits
• adoption assistance
• 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.