Computer System Validation Engineer (Design Group)

Công ty: Barry Wehmiller Design Group
Thể loại công việc: Full-time

Design Group operates from more than 45 offices in the United States and India, providing engineering, consulting and technical services for the worlds leading companies in the food and beverage, life sciences, advanced technology, industrial and other market sectors. Our nearly 1,500 technical and engineering experts have direct industry experience in industrial automation, control system integration, facility and process engineering, architecture, construction management, regulatory compliance, enterprise technology and other consulting services.
Barry-Wehmiller is a diversified global supplier of engineering consulting and manufacturing technology for the packaging, corrugating, sheeting and paper-converting industries. By blending people-centric leadership with disciplined operational strategies and purpose-driven growth, Barry-Wehmiller has become a $3 billion organization with nearly 12,000 team members united by a common belief: to use the power of business to build a better world.
* The Computer System Validation Engineer will interface with our clients and be responsible for preparing and executing computer system validation documents for a variety of distributed control, process control and stand-alone production systems.
* This role will include both document development and execution of computer system validation test scripts, including SFATs, HFATs, traceability matrices, IQs and OQs.
* A working knowledge of, and experience in, generating software development life cycle documentation such as FRSs, SDSs, HDSs and Configuration Specifications.
* Competency with FDA Data Integrity requirements, and exposure to data integrity risk and gap assessments.
* Solid understanding of GAMP and 21 CFR Part 11 requirements.
* Participate in good documentation practices, cGMP, & FDA CQV methods and systems, read engineering documents, set priorities, and work on multiple projects simultaneously.
* Communicate verbally and through technical writing
* Four (4) to Eight (8) years of computer system validation experience in the pharmaceutical, biotech, medical device or other FDA regulated industries.
* Hands-on experience with Emerson DeltaV, Syncade, Allen Bradley PLC, Wonderware, OSI PI, and/or Rockwell software platforms.
* Exposure to CSV for process control systems for clean utilities and bioprocess manufacturing equipment, and laboratory systems.
* Good working knowledge of biologic unit operations, including fermentation and purification methods and equipment.
* Willing and able to travel as necessary for project requirements to include but not be limited to: project installation and start-up activities, client meetings, company sponsored meetings, trainings, industry related seminars, forums, or conventions, etc
* Bachelors Degree in Engineering, computer science or related technical field
_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 worktherefore, people from all backgrounds are encouraged to apply to our positions. Please let us know if you require reasonable accommodations during the interview process. _
Barry-Wehmiller is an equal opportunity employer. M/F/D/V This organization uses E-Verify.
Applicants may be subject to pre-employment screening which may include drug screening, reference checks, employment verifications, background screening and/or skills assessments.
Design Group US Inc

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