Computer System Validation Engineer

Barry-Wehmiller•Boston, MA

4d•Hybrid

About The Position

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. 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. 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.

Requirements

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

Responsibilities

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
Establishes validation standards, develops and executes validation protocols, reports on findings, and oversees resolution of compliance failures or deviation
Develops and maintains validation-related documentation, which may include specifications, SOPs, work instructions, or batch or testing records
Ensures processes, products, equipment, or systems comply with all applicable external regulations or standards
May assist with new equipment purchases or upgrades to existing equipment
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.