Want to know if this job is worth applying to?
Boston, Massachusetts, United States
Onsite
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
You'll work individually and in teams to support capital projects and implement solutions for our clients. Together, you will help our clients make critical changes to improve their performance and realize their most important goals.
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 systemsDevelop documents and execute computer system validation test scripts, including SFATs, HFATs, traceability matrices, IQs, and OQsParticipate in good documentation practices (cGMP and FDA CQV methods and systems)Read engineering documents, set priorities, and work on multiple projects simultaneouslyCommunicate verbally and via technical writingMake 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 industriesCompetency with FDA Data Integrity requirements and exposure to data integrity risk and gap assessmentsA solid understanding of GAMP and 21 CFR Part 11 requirementsExperience in generating software development life cycle documentation such as FRSs, SDSs, HDSs and configuration specificationsHands-on experience with Emerson DeltaV, Syncade, Allen Bradley PLC, Wonderware, OSI PI, or Rockwell software platformAn understanding of laboratory systems and CSV for process control systems for clean utilities and bioprocess manufacturing equipmentA solid working knowledge of biologic unit operations, including fermentation and purification methods and equipmentA willingness to travel for project requirements including installation and start-up activities, client and company sponsored meetings, trainings, industry related seminars, forums, and conventionsA 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.
Feel like you're on the path to becoming a Computer Systems Validation Engineer but you're not quite there yet? We'd love to connect with you to see if we can take you from where you are today and grow you into a Design Group Engineering Consultant. #LI-TH1
Additional Job Description
Establishes validation standards, develops and executes validation protocols, reports on findings, and oversees resolution of compliance failures or deviationDevelops and maintains validation-related documentation, which may include specifications, SOPs, work instructions, or batch or testing recordsEnsures processes, products, equipment, or systems comply with all applicable external regulations or standardsMay assist with new equipment purchases or upgrades to existing equipmentOther duties as assigned
Maintains maps, detail design drawings, graphs, as-built drawings, structural detail drawings and other graphic engineering records.
Collects codes and posts data from prescribed sources for input to computer.
Corrects and updates existing records and prepares data for analysis.
Other duties as assigned
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.
Barry-Wehmiller is an equal opportunity employer. M/F/D/V This organization uses E-Verify.
Company:
Design Group