Computer Systems Validation Engineer

16 hours ago

Boston MA United States PCMC Full time

About Us:

BW Design Group is a fully integrated architecture, engineering, construction, system integration, and consulting firm committed to helping our clients realize their most critical goals from Strategy to Commercialization. As the only firm born from a manufacturing technology company to become an independent and fully integrated firm, we combine deep domain expertise in the manufacturing environment with an approach that is built to serve the dynamic needs of our clients. Rooted in our distinct culture of Truly Human Leadership, we cultivate the leaders who will define tomorrow and partner with our clients in the food & beverage, life sciences, industrial, and advanced technology industries to build the future of manufacturing and technology.

Job Description:

Computer Systems Validation Engineer

Who You’ll Work With:

You will join one of our 45 offices in the US, be part of a committed team of over 1500 professionals, and work in teams and directly with our clients doing work that is shaping the world around us. You will be welcomed into a rapidly growing business and team and empowered to make an impact. You will be valued, cared for, and challenged on your path to becoming a world-class professional consultant and surrounded by leaders who are committed to creating an environment that enables you to realize your own success and fulfillment.

When you join Design Group as a Computer Systems Validation Engineer, you are joining a team that will challenge you and position you for growth. In this role, you will work with a team of industry experts to help the world’s leading companies solve their most difficult problems. You will join our Regulatory Compliance Practice and partner with seasoned leaders, technical specialists, and subject matter experts to deliver the highest quality solutions to our clients with consistency and accuracy.

What You’ll Do:

  • Interface with our clients and take responsibility for preparing and executing computer system validation documents for a variety of distributed control, process control, and stand-alone production systems.
  • Develop documents and execute computer system validation test scripts, including SFATs, HFATs, traceability matrices, IQs, and OQs.
  • Participate in good documentation practices (cGMP and FDA CQV methods and systems).
  • Read engineering documents, set priorities, and work on multiple projects simultaneously.
  • Communicate verbally and via technical writing.
  • Make an impact day-to-day with your skills and expertise, strengthening that relationship with our clients and team.

What You’ll Bring:

  • A minimum of four years of computer system validation experience in the pharmaceutical, biotech, medical device or other FDA regulated industries.
  • Competency with FDA Data Integrity requirements and exposure to data integrity risk and gap assessments.
  • A solid understanding of GAMP and 21 CFR Part 11 requirements.
  • Experience in generating software development life cycle documentation such as FRSs, SDSs, HDSs and configuration specifications.
  • Hands-on experience with Emerson DeltaV, Syncade, Allen Bradley PLC, Wonderware, OSI PI, or Rockwell software platform.
  • An understanding of laboratory systems and CSV for process control systems for clean utilities and bioprocess manufacturing equipment.
  • A solid working knowledge of biologic unit operations, including fermentation and purification methods and equipment.
  • A willingness to travel for project requirements including installation and start-up activities, client and company sponsored meetings, trainings, industry related seminars, forums, and conventions.
  • A bachelor’s degree in engineering, computer science, or related technical field.

Our culture and commitment to our people is what sets us apart. We foster an environment of mutual respect, integrity, and unconditional interest in the individual and collective success of our professionals. Our model and entrepreneurial mindset offer a rewarding, challenging, and highly flexible path. As a Computer Systems Validation Engineer, you will build a meaningful and fulfilling career with the support of professional development resources and mentorships including our First Year Experience program, Individual Development Plans, and Career Path resources and tools. You will be surrounded by exceptional talent who will support your development as both a world-class engineer and a highly effective leader.

At Barry-Wehmiller we recognize that people come with a wealth of experience and talent beyond just the technical requirements of a job. If your experience is close to what you see listed here, please still consider applying. We know that our differences often can bring about innovation, excellence and meaningful work—therefore, people from all backgrounds are encouraged to apply to our positions. Please let us know if you require reasonable accommodations during the interview process.

Company: Design Group

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