Validation Engineering Roles

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.

 

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.

 

Job Description:

Validation Engineering Roles

Who You'll Work With 

Join one of our 45 offices in the US as part of a committed team of over 1500 professionals, working directly with clients on projects that shape the world around us. As a contract professional with BW Design Group, you'll be welcomed into a rapidly growing business and empowered to make an immediate impact. You'll work alongside seasoned leaders, technical specialists, and subject matter experts within our Regulatory Compliance Practice to deliver the highest quality solutions with consistency and accuracy. 

What You'll Do 

You'll support both capital project CQV delivery and individual technical contribution solutions for our clients within the Life Sciences industry. You'll help clients implement critical changes to improve their performance and realize their most important goals through: 

Validation & Compliance Activities: • Assist basic and conceptual design phases of capital projects by working with clients and vendors on embedding compliance, testability and lifecycle thinking into early design • Establish User Requirement Specifications for critical equipment and systems. • Assess risk across various aspects of systems’ functions and focus efforts on critical quality aspects.  Develop and execute validation and FDA compliance related documents/protocols for pharmaceutical equipment and processes – employing industry’s most progressive Digital Validation Tools • Prepare, execute, and manage commissioning and qualification documents for utility, facility, and process equipment • Perform FAT, SAT, IQ, and OQ documentation development and execution on Automated Systems • Conduct investigations and troubleshoot validation-related issues • Prepare comprehensive written validation reports. 

Project Management & Leadership: • Lead all aspects of client relationship development and project execution • Develop project plans, strategies, and manage project resources, budgets, and schedules • Oversee complete project lifecycle from concept through design, implementation, installation, commissioning, and startup • Manage multiple project responsibilities simultaneously with excellent organizational skills • Focus on project success related to scope, schedule, budget, and client satisfaction 

What You'll Bring 

Experience Requirements (Based on Role Level):  

• Validation Engineer II: Minimum 2-7 years project experience with validation of automation, packaging, drug substance (i.e., pooling, centrifugation, TFF) and/or drug product (i.e., filling, inspection) systems/equipment, utilities, and/or facilities in pharmaceutical or medical device environments  

• Sr. Validation Engineer: Minimum 7+ years demonstrated experience with design, commissioning, validation of automation, packaging drug substance (i.e., pooling, centrifugation, TFF) and/or drug product (i.e., filling, inspection) systems/equipment, utilities, and/or facilities in pharmaceutical or medical device environments   validation  

• Sr. Project Manager: Minimum 10+ years project engineering, design engineering, or project management experience with packaging, processing, automation, or Life Science applications.  

Technical Skills & Qualifications: • Bachelor's degree in Engineering (Bioengineering, Biomedical, Chemical, Electrical, Mechanical