Design Group
manufacturing technology
Sr.ValidationEngineer
Neural analysis suggests this role is
optimal for Senior candidates.
“Sr. Validation Engineer at Design Group. Skills: Validation, Commissioning, Qualification, GMP. Support capital project CQV delivery. Perform individual technical contribution”
What You'll Achieve.
Help clients realize their most critical goals; Improve client performance; Realize client's most important goals; Deliver the highest quality solutions to our clients with consistency and accuracy
Industry & Context.
Analytical capabilities; Troubleshoot validation-related issues
Willing and able to travel as necessary for project requirements including installation, startup activities, client meetings, and industry events
What They're Looking For.
Must Have
Minimum 7+ years demonstrated experience with design, commissioning, validation of automation, packaging drug substance and/or drug product systems/equipment, utilities, and/or facilities pharmaceutical or medical device environments validation, Extensive hands-on experience with GMP-regulated environments, Knowledge of regulation and guidance _’_ s (i. e. , CFR Parts 210, 211, 11), Annex 1, ICH Q7/Q8/Q9, ISPE G2G), Experience with implementing risk-based approaches to validation projects, Authoring, reviewing and approving Validation Master Plans, risk assessments, deviations, and change controls, Bachelor's degree in Engineering (Bioengineering, Biomedical, Chemical, Electrical, Mechanical, or equivalent technical degree), Validation experience in automation, packaging, general drug substance and/or drug product systems/equipment, computer systems, utilities, and/or facilities, technical writing and oral communication skills, Proficiency with project documentation and computer skills (Microsoft Office, Microsoft Project, AutoCAD)
Nice to Have
Experience with entire project lifecycle from concept development through startup
What You'll Do.
Support capital project CQV delivery
Perform individual technical contribution
Assist basic and conceptual design phases
Establish User Requirement Specifications
Assess risk across systems
Develop and execute validation and FDA compliance documents/protocols
and manage commissioning and qualification documents
and OQ documentation development and execution
Conduct investigations and troubleshoot validation-related issues
Prepare comprehensive written validation reports
How You'll Work.
Team & Collaboration
Work individually and in teams; Work with clients and vendors; Partner with seasoned leaders, technical specialists, and subject matter experts; Interact with all levels of management, clients, and vendors; Develop long-lasting relationships with clients and project teams
Communication Scope
Technical writing; Oral communication; Communication skills; Interpersonal skills
Process & Methodology
Manage multiple responsibilities, Project lifecycle management
Full Job Description
**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:** _Sr. 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 Sr. 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 i
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