Validation Engineer - Experienced

Barry-Wehmiller • Raleigh, NC

13d

About The Position

BW Design Group is a fully integrated architecture, engineering, construction, system integration, and consulting firm serving clients in food and beverage, life sciences, industrial, and advanced technology industries. The company is part of Barry-Wehmiller, a global supplier of engineering consulting and manufacturing technology.

The Validation Engineer joins Design Group’s Regulatory Compliance Practice and works with industry experts, technical specialists, and clients to support capital projects and implement solutions. The role develops and executes validation and FDA-compliance documentation and protocols for pharmaceutical equipment, supports manufacturing-process design and project delivery, and prepares written validation reports. The position involves travel to client sites across the country as required for project work, including installation and start-up activities.

The engineer also supports quality management system procedures and applicable pharmaceutical and medical-device standards and regulations. The role offers professional development resources and mentorship, including the First Year Experience program, Individual Development Plans, and Career Path resources and tools.

Requirements

• Bachelor of Science in Bioengineering, Biomedical Engineering, Chemical Engineering, or a related technical discipline.
• Good communication and interpersonal skills.
• Flexibility with tasks and ability to interact with management at all levels, clients, and vendors.
• Strong technical writing and oral communication skills.
• Strong computer skills, including Microsoft Office, Microsoft Project, and AutoCAD.
• Willingness and ability to travel as necessary for project requirements.
• At least 3 years of project experience validating automation, packaging, utilities, and/or facilities is desired.

Nice To Haves

• At least 3 years of project experience in pharmaceutical or medical-device environments.

Responsibilities

• Develop and execute validation and FDA-compliance documents and protocols for pharmaceutical equipment.
• Develop and execute FAT, SAT, IQ, and OQ documentation for automated systems in the pharmaceutical industry.
• Assist with the development and execution of QMS procedures and stability protocols and reports, and support compliance with ICH Q1, Q8, Q9, and Q10, CFR 21 Part 211, and CFR 21 Part 820.
• Work with teams to investigate and troubleshoot validation-related issues.
• Prepare written validation reports.
• Support capital projects and implement client solutions, including work related to manufacturing processes, project management, and facility development.
• Travel as required for project installations and start-ups, client and company meetings, training, and industry events.
• Build and maintain effective relationships with clients and the project team.

Benefits

• Professional development resources and mentorship, including the 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