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 an experienced Senior Commissioning, Qualification & Validation (CQV) Engineer to support a large-scale pharmaceutical manufacturing tech transfer project involving the relocation and expansion of derivatization, conjugation, and alum adsorption processes. This individual will lead CQV activities from FEL-3 through Performance Qualification (PQ), ensuring systems are commissioned, qualified, and validated in compliance with GMP requirements while supporting implementation of single-use technologies, MES integration, and electronic batch records.

The successful candidate will have extensive experience qualifying biopharmaceutical process equipment, managing validation lifecycle documentation, and driving execution within a fast- paced capital project environment.

Role accountabilities:

• Lead CQV activities from design through PQ execution.
• Develop and execute Commissioning & Qualification Plans aligned with project requirements.
• Author, review, and obtain approval for: o User Requirement Specifications (URS) o System Level Impact Assessments (SLIA) o Component Level Impact Assessments (CLIA) o Design Qualification Assessments (DQA) o Test Plans (TP) o Requirements Traceability Matrix (RTM) o Equipment Turnover Checklists (ETC)
• Support FAT and SAT activities and coordinate vendor interactions.
• Execute and document Installation & Operational Commissioning (IOC).
• Execute Installation & Operational Qualification (IOQ) protocols.
• Support Performance Qualification (PQ), process validation, and process simulation activities.
• Conduct component verification, installation checks, alarm testing, TOP reviews, and operational testing.
• Participate in design reviews, CCR reviews, risk assessments, and project meetings.
• Collaborate with engineering, operations, automation, quality, validation, and project management teams.
• Support implementation of MES, electronic batch records, and data integrity requirements. CQV Engineer TSO826640NJ West Point, PA

• Utilize eVal or equivalent electronic validation systems for protocol development and execution.
• Other duties as assigned

Qualifications & Experience:

• Bachelor's Degree in Engineering, Life Sciences, Biotechnology, or related technical field.
• 7+ years of CQV, Validation, or Commissioning experience within GMP-regulated pharmaceutical or biotechnology environments.
• Strong experience supporting capital projects, facility expansions, or technology transfers.
• Experience authoring and executing validation lifecycle documentation.
• Working knowledge of cGMP, FDA, ISPE, ASTM, and GAMP guidance.
• Experience performing FAT, SAT, IOQ, and PQ activities.
• Experience with process equipment qualification and utility systems.
• Strong understanding of change control, deviation management, and quality systems.

Preferred Qualifications

• Experience supporting vaccine or biologics manufacturing facilities.
• Experience with tangential flow filtration (TFF), single-use systems, and conjugation processes.
• Experience with MES platforms and electronic batch records.
• Prior experience with eVal validation software.
• Familiarity with EPCM project execution models.
• Experience supporting technology transfer projects from development through commercial manufacturing.
• 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 CQV Engineer TSO826640NJ West Point, PA

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.