CSV Engineer

7 days ago

Durham NC United States Arcadis Full time

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 looking for a CSV Engineer in Durham, NC. This individual must have relevant experience supporting the CSV life cycle in a cGMP environment.


Responsibilities

  • Provide support for Commissioning and Qualification activities for the required system.
  • Author and execute Commissioning and Qualification documents, including, but no limited to:
  • URS
  • Qualification Plans
  • Development Protocols
  • Specifications (Configuration, Software, Design, Functional)
  • Risk Assessments
  • Qualification Protocol(s) including deviation support during physical execution
  • Qualification Reports
  • Ensure design specifications are in alignment with qualification strategy and procedures.
  • Collaborate and work directly with the team members to complete project deliverables. Ensure to stay informed on general project information including but not limited to decisions, changes, plans of work, due dates, and issues.
  • Attend project meetings related to implementation, document reviews, and schedule reviews.
  • Track deliverables and milestones and escalate delays to Validation Management.
  • Escalate project or technical changes, issues, risks, and outstanding decisions to Validation Management.
  • Other duties as assigned

Qualifications & Experience:

  • Bachelor's Degree in engineering or related field
  • Validation related experience
  • Knowledge of writing and reviewing validation documentation
  • Good understanding of IQ, OQ, PQ, RTM, Test Scripts, Summary Reports, etc
  • Strong Attention to Detail
  • Self-motivated and reliable
  • Knowledge of PC computer operating systems and the Microsoft Office suite
  • Strong written and oral communication skills
  • 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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