Validation Engineer

Barry-Wehmiller•Fort Worth, TX

3d•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. When you join Design Group as a 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 passion for a career in the Life Science industry
Excellent communication and interpersonal skills and ability to interact with all levels of management, clients, and vendors
Bachelor’s degree in Bioengineering, Biomedical Engineering, Chemical Engineering, or similar technical degree preferred.
Project experience in a cGMP manufacturing environment such as pharmaceutical, biotech, or medical device facility
Project Experience with authoring and executing validation protocols of automation/computerized systems, QC Laboratory equipment, packaging systems, and/or utilities and facilities is desired
Proficient computer skills (Microsoft Office, Microsoft Project, & AutoCAD)
Proficient with written and verbal technical communication including generating reports and conducting group presentations.
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.

Responsibilities

Deliver Commissioning and Qualification (C&Q) solutions and services for client facility, utility, process, and equipment
Develop and execute a variety of validation and FDA compliance related documents/protocols
Author specifications, assessments, and test protocols across a diverse Life Science market comprised of Pharmaceuticals, Biotechnology, Cell & Gene Therapy, and Medical Device clients
Assist in the development and implementation of Quality Management System (QMS) procedures, in harmony with regulatory standards such as ICH Q1, CFR 21 Part 210 and 211, CFR 21 Part 820, ICH Q8, ICH Q9, and ICH Q10, and 21 CFR Part 11.
Collaborate with teams to perform investigations, diagnose problems, and troubleshoot validation issues
Prepare written validation reports with high level of detail and organization
Communicate with project stakeholders the progress relative to plan
Manage project deliverables to agreed schedule and scope
Make an impact day-to-day with your skills and expertise, strengthening that relationship with our clients and team.