Demo

CQV Engineer

Arcadis
Cambridge, MA Full Time
POSTED ON 1/8/2025
AVAILABLE BEFORE 2/5/2025

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 Engineer who is responsible for executing and managing QC lab analytical equipment activities to meet cGMP requirements. He/She will initiate equipment validation protocol development, including drafting documents, managing review cycles, and protocol approval.

Role accountabilities:

Become familiar with the user, functional, installation, operation and performance requirements for assigned projects and tasks.

Review requirements and source documentation P&IDs, RDs, URSs, SOPs, Specifications), for use in development of equipment commissioning and validation documents.

Equipment validation protocol development, including drafting documents, managing review cycles and protocol approval.

Execution of equipment validation protocols

Support Equipment Validation Report development, including drafting documents, managing review cycles and protocol approval.

Support Validation Summary Report development

Provide support for generation, resolution and closure of Equipment Validation related deviations and required documentation.

Assist with coordination of activities between Client teams (validation, engineering, manufacturing, QC, etc.).

Support resolution of engineering/validation issues found during equipment validation.

Attending meetings as required to support equipment installation and operation

Providing quality oversight and approval for validation documents as needed. (Function test, IQs, OQs, etc…)

Support developing SOP’s.

Other tasks as requested or required by Client to support Equipment Validation for each project.

Preforming CQV activities on QC Lab and analytical equipment

Other duties as assigned

Qualifications & Experience:

  • BS (MS preferred), in Industrial, Process, Mechanical, or Chemical Engineering
  • Experience preforming CQV activities for QC Lab and analytical equipment
  • Experience working in a multi-disciplinary design office or equivalent client team
  • Demonstrated CQV experience in design consultancy and/or client-site environments
  • Knowledge of typical biotech/pharmaceutical manufacturing systems and equipment
  • Excellent communication skills, both written and verbal
  • Excellent teamwork and interpersonal skills
  • Excellent analytic, problem-solving and decision-making skills
  • Advanced time management and organizational skills
  • Leadership skills, with a view to managing people
  • Results and customer-oriented, strong communication skills
  • Demonstrated ability to learn and quickly apply new concepts and technical information
  • 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.

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