Validation Engineer - Experienced

Barry-Wehmiller • Raleigh, NC

1d • 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

• Candidates need to possess good communication and interpersonal skills, flexibility with tasks and the ability to interact with all levels of management, clients, and vendors
• Strong technical writing and oral communications
• Strong computer skills (Microsoft Office, Microsoft Project, & AutoCAD)
• 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.
• B.S. in Bioengineering, Biomedical Engineering, Chemical Engineering, or related technical degree.

Nice To Haves

• Minimum of 3 years project experience with validation of automation, packaging, utilities and/or facilities is desired
• Minimum of 3 years project experience in the pharmaceutical or medical device environments is a plus

Responsibilities

• Responsible for developing and executing a variety of validation and FDA compliance related documents/protocols for pharmaceutical equipment.
• Travel to top clients across the country to assist in the design of manufacturing processes, help manage projects, develop facilities, and impact the world by conducting themselves with integrity in pursuit of individual and enterprise goals.
• FAT, SAT, IQ and OQ documentation development and execution on Automated Systems in the pharmaceutical industry
• Assist in the development and execution of QMS procedures, ICH Q1 (Stability Protocols / Reports), CFR 21 Part 211, CFR 21 Part 820, ICH Q8, ICH Q9, and ICH Q10
• Work with teams to perform investigations and troubleshoot issues related to validation
• Prepare written validation reports
• Make an impact day-to-day with your skills and expertise, strengthening that relationship with our clients and team

Benefits

• professional development resources and mentorships including our First Year Experience program, Individual Development Plans, and Career Path resources and tools.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level