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Validation Engineer

Arcadis
Cambridge, MA Full Time
POSTED ON 1/30/2025
AVAILABLE BEFORE 4/27/2025

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 Validation Engineer to join our team and play a critical role in ensuring compliance with industry standards and regulatory requirements for our products and processes. The ideal candidate will have expertise in validation processes and protocols, particularly in the pharmaceutical or biotech industry with a focus on sterilization, environmental monitoring, and utility systems.

Role accountabilities :

Autoclave Cycle Development and Performance Qualification (PQ) :

  • Develop and optimize autoclave sterilization cycles to ensure product sterility and compliance with regulatory standards.
  • Conduct validation studies, including cycle development, load configuration, and validation execution.
  • Analyze and interpret data to confirm process reliability and effectiveness.

Environmental Monitoring (EM) Performance Qualification (PQ) :

  • Perform risk assessments related to environmental monitoring to identify critical control points.
  • Generate and execute PQ protocols for EM systems to ensure compliance with regulatory guidelines.
  • Collaborate with cross-functional teams for EM validation activities (excluding sampling tasks).
  • Utility System PQs :

  • Create and execute Performance Qualification (PQ) protocols for utility systems, including Water for Injection (WFI), compressed air systems, CO2, and O2.
  • Ensure that utility systems meet required specifications for purity, flow, pressure, and other critical parameters.
  • Document and report validation results in accordance with GMP (Good Manufacturing Practices) and company standards.
  • Other duties as assigned
  • Qualifications & Experience :

  • Bachelor’s degree in Engineering (e.g., Mechanical, Chemical, Biomedical, or related field) or equivalent experience in validation.
  • 3 years of experience in validation activities within the pharmaceutical, biotechnology, or medical device industry.
  • Strong knowledge of regulatory requirements (e.g., FDA, EMA, ISO 13485, GMP).
  • Experience with autoclave sterilization processes and utility systems validation.
  • Proficiency in risk assessments, protocol generation, and execution.
  • Excellent attention to detail, data analysis, and technical writing skills.
  • Ability to work collaboratively in cross-functional teams.
  • 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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