Validation Engineering Roles

Barry-Wehmiller•Columbia, MD

32d

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. 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. 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

Requirements

Validation Engineer II: Minimum 2-7 years project experience with validation of automation, packaging, utilities, and/or facilities in pharmaceutical or medical device environments
Sr. Validation Engineer: Minimum 7+ years demonstrated experience with pharmaceutical or medical device process and equipment validation
Sr. Project Manager: Minimum 10+ years project engineering, design engineering, or project management experience with packaging, processing, automation, or Life Science applications.
Bachelor's degree in Engineering (Bioengineering, Biomedical, Chemical, Electrical, Mechanical, or equivalent technical degree)
Validation experience in automation, packaging, cleaning, computer systems, utilities, and/or facilities
Strong technical writing and oral communication skills
Proficiency with project documentation and computer skills (Microsoft Office, Microsoft Project, AutoCAD)
Excellent leadership and organizational skills with ability to manage multiple responsibilities
Outstanding communication and interpersonal skills to interact with all levels of management, clients, and vendors
Flexibility with tasks and strong analytical capabilities
Willing and able to travel as necessary for project requirements including installation, startup activities, client meetings, and industry events.
Must be legally authorized to work in the United states without sponsorship

Nice To Haves

Experience with entire project lifecycle from concept development through startup (preferred)

Responsibilities

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.
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